Bit, Surgical
FDA adverse event reports and recall history for bit, surgical (product code GFG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 666
- Deaths
- 0
- Injuries
- 127
- Malfunctions
- 535
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
- 2014-05-29TerminatedProcess control
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
- 2005-12-28TerminatedOther
Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
The bit may bend or fracture during use.
- 2005-10-28TerminatedOther
Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.
The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- TerminatedDevice Design
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Monitor bit, surgical automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.