NA 398.65Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982201492), received between Aug 27, 2015 and Sep 20, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 WHILE STERILE PROCESSING DEPARTMENT WAS INSPECTING INSTRUMENT, FOUND TO BE BROKEN. THE LOCKING MECHANISM BROKE OFF OF THE GRIPPING HANDLE. THIS REPORT IS FOR ONE (1) FORCEPS FOR BROKEN SCREW REMOVAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268915 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A STERILE PROCESSING TIP WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) FORCEPS FOR BROKEN SCREW REMOVAL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453602 ↗
• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A PIECE OF RATCHETING TRACK ON THE REMOVAL FORCEPS BROKE OFF. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A FORCEPS FOR BROKEN SCREW REMOVAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15313888 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, ONE (1) PELVIC REDUCTION FORCEP, ONE (1) LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE (1) DEPTH GAUGE FOR LOCKING SCREW, FOUR (4) UNIVERSAL CHUCK WITH T-HANDLE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE (1) PELVIC REDUCTION FORCEP, TWO (2) RIA DRIVE SHAFT, ONE (1) BENDING PLIERS, ONE (1) FORCEP FOR BROKEN SCREW REMOVAL, ONE (1) LOCKING PLIER, TWO (2) LARGE QUICK COUPLING, ONE (1) DEPTH GAUGE, ONE (1) SILICONE HANDLE, ONE (1) RED FORCEPS SERRATED JAW RATCHET, ONE (1) PLATE HOLDING FORCEP, ONE (1) REDUCTION FORCEP WITH POINT RATCHET, ONE (1) HOLDING SLEEVE WITH WING SCREW, ONE (1) GRAPHIC CASE AND TWO (2) GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) FORCEPS FOR BROKEN SCREW REMOVAL. THIS IS REPORT 10 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584748 ↗
• MalfunctionFeb 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, BQ-SYNTHES RECEIVED A FORCEPS WITH A BROKEN RATCHET LOCK. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) FORCEPS FOR BROKEN SCREW REMOVAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368266 ↗
• MalfunctionDec 21, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS NOTICED THAT THE FORCEPS FOR BROKEN SCREW REMOVAL HAD MALFUNCTIONED. IT IS NOT KNOWN HOW OR WHEN THE ISSUE OCCURRED OR IF THERE WAS ANY PATIENT INVOLVEMENT. INVESTIGATION OF THE RETURNED DEVICE REVEALED THE LEAF SPRING IS BROKEN. THIS REPORT IS FOR ONE (1) FORCEPS FOR BROKEN SCREW REMOVAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191645 ↗
• MalfunctionFeb 27, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE JAW AT THE DISTAL END OF THE FORCEPS FOR BROKEN SCREW REMOVAL BROKE OFF. IT IS NOT KNOWN HOW OR WHEN THE ISSUE OCCURRED, NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) FORCEPS FOR BROKEN SCREW REMOVAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300147 ↗
• MalfunctionApr 24, 2017Break; Break

  IT WAS REPORTED BY SERVICE AND REPAIR THAT ON (B)(6) 2017 THAT THE HOSPITAL RETURNED THE FORCEPS FOR BROKEN SCREW REMOVAL INSTRUMENT WITH A BROKEN LATCH. A INSTRUMENT FRAGMENT WAS ALSO RETURNED. IT IS UNKNOWN WHEN THE INSTRUMENT BROKEN AND THE HOSPITAL PERSONNEL HAS NO ADDITIONAL INFORMATION ON THIS ITEM. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6515255 ↗
• MalfunctionAug 27, 2015Break

  IT WAS REPORTED THAT THE FORCEPS FOR BROKEN SCREW REMOVAL WAS FOUND TO BE BROKEN WHEN IT WAS BROUGHT INTO THE STERILE PROCESSING DEPARTMENT. THE HANDLE OF THE FORCEPS WERE FOUND BROKEN. THE DEVICE WAS FOUND BROKEN WHILE STILL IN THE TRAY; IT WAS NEVER USED OR PUT INTO CIRCULATION AT THE HOSPITAL. NO PATIENT INVOLVEMENT. IT WAS NOT USED IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 5034276 ↗