NA 399.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982202253), received between Jan 31, 2017 and Apr 5, 2019 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF DISTAL HUMERUS, THE TIP OF THE REDUCTION FORCEP WITH SEPARATED JAW BROKE OFF WHILE TRYING TO HOLD A REDUCTION. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ANOTHER CLAMP WAS USED TO FINISH THE CASE SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN REDUCTION (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488862 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, UPON INSPECTION IN THE STERILE PROCESSING, THE REDUCTION FORCEPS WITH SERRATED JAW SPEED LOCK WAS FOUND BROKEN IN A LARGE BONE FORCEP TRAY AND WAS MISSING THE NUT THAT HOLDS THE SPINDOWN ATTACHMENT INTO THE CLAMP. THERE WAS NO PATIENT INVOLVEMENT.  THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8287499 ↗
• MalfunctionNov 21, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) REDUCTION FORCEPS WITH SERRATED JAW WAS DISCOVERED TO HAVE A BROKEN TIP ON THE CLAW. IT IS UNKNOWN IF THERE WAS PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A REDUCTION FORCEPS WITH SERRATED JAW. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096722 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, WHILE THE SURGEON WAS CLAMPING THE BONE, THE REDUCTION FORCEPS WITH SERRATED JAW BROKE. THERE WERE FRAGMENTS GENERATED BUT WERE EASILY REMOVED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7823172 ↗
• MalfunctionApr 18, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY A PAIR OF REDUCTION FORCEPS BROKE. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7440658 ↗
• MalfunctionJul 26, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017 THAT THE REDUCTION FORCEPS WITH SERRATED JAW ARE BROKEN INTO TWO PIECES, THE FORCEPS FOR BROKEN SCREW REMOVAL WILL NOT HOLD AND ARE NOT RATCHETING AND THE REDUCTION FORCEPS WITH SERRATED JAW WILL NOT HOLD AND ARE LOOSE. ALL THREE DEVICES WERE FOUND IN A BIN IN THE STERILE PROCESSING. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6744446 ↗
• InjuryMar 13, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT WHILE CLAMPING THE PLATE TO THE BONE, FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF A RIGHT DISTAL TIBIA, THE TIP OF ONE OF THE POINTS ON THE REDUCTION FORCEPS BROKE OFF. THE SURGEON DID NOT REALIZE THAT THE TIP ON THE REDUCTION FORCEPS HAD BROKEN OFF UNTIL FINAL X-RAYS WERE COMPLETED. AS IT WAS UNKNOWN TO THE SURGEON THAT THE TIP HAD BROKEN OFF, THE PROCEDURE CONTINUED. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH AN ANTERIOR LATERAL DISTAL TIBIA PLATE AND SCREWS. THE REDUCTION FORCEPS PERFORMED ITS INTENDED FUNCTION OF CLAMPING THE PLATE TO THE BONE. WHEN FINAL X-RAYS WERE TAKEN, THE SURGEON NOTED THE PRESENCE OF THE BROKEN TIP ON THE MEDIAL SIDE OF THE DISTAL TIBIA. THE SURGEON USED AN INSTRUMENT/FORCEPS TO RETRIEVE THE BROKEN TIP. RETRIEVAL DID NOT REQUIRE AN ADDITIONAL INCISION. THE SURGERY WAS DELAYED APPROXIMATELY 4-5 MINUTES TO RETRIEVE THE BROKEN TIP. ANOTHER INTRAOPERATIVE X-RAY WAS TAKEN TO ENSURE THAT THE BROKEN TIP WAS RETRIEVED. THE BROKEN TIP WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT¿S CONDITION WAS REPORTED AS STABLE. THE REDUCTION FORCEPS BROKE ON THE BONE SIDE NOT THE PLATE SIDE. ON THE LATERAL SIDE OF THE

  Patient problems: No Code Available

  MAUDE report 6400770 ↗
• MalfunctionJan 31, 2017Break; Break

  IT WAS REPORTED THAT A BROKEN REDUCTION FORCEPS WITH SERRATED JAW WAS REPORTED BY STERILE PROCESSING. THE DEVICE WAS BROKEN INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH SERRATED JAW 240MM ¿SPEED LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6291098 ↗