NA 398.88Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982201928), received between Jan 23, 2020 and Sep 15, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE FORCEP'S SCREW FELL OUT, CAUSING THE DEVICE TO SPLIT IN TWO PIECES. ALSO, SILVER CAP ON BACK OF THE SCREWDRIVER FELL OUT. NO OPERATION INVOLVED. NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052530 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED POST OPERATIVELY ON (B)(6) 2025, THE CLAMP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381573 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, WHEN THE BROKEN PELVIC REDUCTION FORCEPS WHICH ONE OF THE PARTS OF INSTRUMENT SET, WAS GOING TO BE REPLACED. IT WAS CONFIRMED THAT THE SIZE OF ANOTHER PELVIC REDUCTION FORCEPS WHICH SUPPOSED TO BE INTO THE SET INSTEAD OF THE BROKEN ONE HAD BEEN CHANGED AND UNABLE TO BE PLACED IN THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942618 ↗
• 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) PELVIC REDUCTION FORCEPS. THIS IS REPORT 1 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584393 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PELVIC REDUCTION FORCEPS WAS FOUND IN STERILE PROCESSING DEPARTMENT, BROKEN APART WITH THE CENTER BOLT BROKEN OUT OF THE MIDDLE OF INSTRUMENT. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) PELVIC REDUCTION FORCEPS THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11709326 ↗
• MalfunctionJan 23, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LARGE PELVIC REDUCTION FORCEPS WERE BROKEN. THE ISSUE WAS DISCOVERED AFTER THE REPORTED DEVICE WAS RETURNED IN A FLASH PAN WITH THE OTHER INSTRUMENTS USED IN AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ACETAB PROCEDURE ON (B)(6) 2020. IT WAS MENTIONED THAT THE DEVICE WORKED CORRECTLY DURING THE PROCEDURE AND HAD NO ISSUES UNTIL THE INSTRUMENTS WERE PUT BACK INTO THEIR SETS FOR THE NEXT SURGERY. THERE WAS NO PATIENT ADVERSE CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) PELVICREDUCFORCEPS LRG ADJUST SPEED-LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9623621 ↗