NA 399.091Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982202314), received between Apr 20, 2017 and May 6, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Break; Break

  THIS REPORT IS FOR ONE (1) BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE.THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250958 ↗
• MalfunctionDec 9, 2021Break

  IT WAS REPORTED THAT FOLLOWING WASH ON AN UNKNOWN DATE, SEVERAL PRODUCTS WERE FOUND TO BE FAULTY. UPON MANUFACTURER INVESTIGATION, THE DEVICE WAS DISCOVERED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A BONE HOLDING FORCEPS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970234 ↗
• MalfunctionApr 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPRING BLADE INSIDE THE CLAMP BROKE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684760 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, THE BONE HOLDING FORCEPS - SOFT RATCHET F/PLATES TO 9MM WIDE WAS BROKEN. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR 1 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113360 ↗
• MalfunctionNov 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IN WAS REPORTED THAT A BONE HOLDING FORCEPS WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317539 ↗
• MalfunctionJun 28, 2019Break; Break

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743819 ↗
• MalfunctionFeb 11, 2019Break; Material Twisted/Bent; Mechanical Jam; Break; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING STERILIZATION AND INSPECTION, THE JAW PART OF A BONE HOLDING FORCEPS WAS FOUND OUT NOT ALIGNING OR CLOSING PROPERLY AND DOES NOT CLAMP DOWN ALL THE WAY. IT WAS NOTED THAT THE INSTRUMENT WAS DIFFICULT TO USE AND THE MECHANISM STICKS. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8325545 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A BONE HOLDING FORCEPS SOFT RATCHET CLAMP WAS BROKEN WHEN ATTEMPTED TO USE . THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE HOLDING FORCEPS-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8274937 ↗
• MalfunctionDec 7, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE TO REPAIR A SPIRAL FRACTURE OF THE HUMERUS, IT WAS NOTED THE BONE HOLDING FORCEPS IN THE SET WAS BROKEN INTO 2 PIECES. ANOTHER FORCEPS WAS READILY AVAILABLE AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN SURGERY AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM. PATIENT WAS REPORTED STABLE POST-OPERATIVELY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7097094 ↗
• MalfunctionApr 20, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA SHAFT TO TREAT A FRACTURE. WHILE THE SURGEON WAS USING THE REDUCTION FORCEPS ONE OF THE HANDLES SNAPPED AND WAS PARTIALLY DETACHED. THAT INSTRUMENT WAS SET ASIDE AND AN ALTERNATE WAS AVAILABLE FOR THE SURGEON TO USE AND SUCCESSFULLY COMPLETE THE PROCEDURE. AFTER THE INSTRUMENT WENT THROUGH STERILIZATION PROCESS IT BROKE INTO (2) SEPARATE PIECES. THERE WAS NO SURGICAL DELAY TO THE PROCEDURE. NO HARM WAS REPORTED TO THE PATIENT. THE PATIENT OUTCOME WAS STABLE. REPORTEDLY, THE INSTRUMENT HAD BEEN IN USE A LONG TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6508344 ↗