Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2014-06-25TerminatedProcess design

  ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-06-25TerminatedProcess design

  ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-06-25TerminatedProcess design

  ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems

  The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

• 2014-04-30TerminatedComponent design/selection

  PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

  The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.

• 2014-03-20TerminatedEmployee error

  2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

  Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm 7cm.

• 2014-01-16TerminatedUnknown/Undetermined by firm

  Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

  Product did not reach expected sterility assurance level

• 2014-01-09TerminatedComponent design/selection

  ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

  The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

• 2014-01-09TerminatedComponent design/selection

  ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

  The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

• 2013-07-16TerminatedProcess change control

  Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

  The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100

• 2013-07-16TerminatedProcess change control

  CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

  The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100