NA 399.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982202390), received between Jan 16, 2017 and Feb 18, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR PERIPROSTHETIC FEMORAL FRACTURES. THE FORCEPS IN QUESTION WERE USED FOR REDUCTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. POSTOPERATIVE RADIOGRAPHS REVEALED THAT THE TIP OF THE FORCEPS HAD BROKEN OFF AND REMAINED INSIDE THE PATIENT¿S BODY. THERE ARE NO PLANS FOR SURGERY TO REMOVE THE BROKEN TIP OF THE FORCEPS. THE SURGEON REQUESTED THE PACKAGE INSERT AND THE INFORMATION REGARDING THE MATERIAL COMPOSITION BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24376618 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE THE RIGHT JAW OF THE SERRATED CLAMP BROKE OFF WHEN THE CLAMP WAS CLOSED OVER A FRACTURE. THE DEVICE WAS DESCRIBED AS FAIRLY NEW, WITH NO UNUSUAL USE NOTED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023733 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE LOCKING MECHANISM OF THE RATCHETING FORCEPS WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889385 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE TIP OF THE LARGE REDUCTION CLAMP SNAPPED OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336892 ↗
• MalfunctionApr 18, 2024Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF FOR DISTAL TIBIA FRACTURE. TO AIM FOR PROPER REDUCTION AND FIXATION, A FORCEPS WAS TRIED BUT IT WAS NOTED TO BE BROKEN. ANOTHER ONE WAS USED INSTEAD FOR THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO HEALTH HARM. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132831 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE INSTRUMENT WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115056 ↗
• MalfunctionAug 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING SURGERY, THE FORCEPS DAMAGED DURING USE. FORCEPS WERE DAMAGED, EVEN THOUGH THEY WERE NOT USED MANY TIMES. THE FORCEPS WERE PURCHASED LAST YEAR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS DETERMINED THROUGH INVESTIGATION THAT THE DEVICE BROKE IN TWO PIECES. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THIS REPORT IS FOR ONE REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441481 ↗
• MalfunctionMay 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT THE BONE FORCEP TIP BROKE OFF WHILE USING IN A CASE. THIS COMPLAINT INVOLVES ONE(1) DEVICE RED FRCP SERRATD JAW-LG HNDL-SOFT RATCHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14499701 ↗
• MalfunctionNov 16, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MOVING PART OF THE FORCEPS WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819873 ↗
• MalfunctionApr 7, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY FOR THE FEMORAL DIAPHYSIS FRACTURE. WHEN THE SURGEON USED THE REDUCTION FORCEPS TO REDUCE THE FEMORAL DIAPHYSIS, THE RIGHT END OF THE REDUCTION FORCEPS WAS BROKEN ABOUT 1 CM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631321 ↗
• MalfunctionJan 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE REDUCTION FORCEPS BROKE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156333 ↗
• MalfunctionJul 2, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, REDUCTION FORCEPS BROKE WHILE REDUCING A FRACTURE AND HOLDING A PLATE. THERE WAS NO PATIENT INVOLVEMENT. THE OUTCOME OF THE PROCEDURE WAS NOT REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATE: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10227606 ↗
• MalfunctionJun 19, 2020Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2020, A SURGICAL BONE CLAMP BROKE DURING SURGERY. THE BROKEN PIECE WAS FOUND IN ITS ENTIRETY AND MATCHED TO THE INSTRUMENT. NO EVIDENCE THAT FOREIGN OBJECT WAS LEFT WITHIN PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES 1 REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173399 ↗
• MalfunctionNov 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING STERILE PROCESSING, THREE (3) FORCEPS DO NOT STAY CLAMPED, ONE (1) FORCEPS HAS A BROKEN TIP, TWO (2) SCREWDRIVERS HAS A BROKEN TIP, ONE (1) SCREWDRIVER HAS A LOOSE BOTTOM PIECE, TWO (2) LARGE QUICK COUPLING AO ADAPTER WAS BROKEN. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9335286 ↗
• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT DURING CLEANING IN THE STERILE PROCESSING DEPARTMENT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP OF AN INTER-LOCK SCREWDRIVER WAS SLIGHTLY TWISTED, AND THE SLIDING PIECE DOESN¿T FIT IN WHILE THE FLAT METAL SPRING OF A REDUCTION FORCEPS WAS FOUND TO BE COMPLETELY BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET. THIS IS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9175610 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A REDUCTION FORCEPS BROKE ON ONE SIDE UPON TRYING TO REDUCE TWO BONE FRAGMENTS TOGETHER AND WHILE EXERTING FORCE. THE SURGERY WAS SUCCESSFULLY COMPLETED BY USING AN ALTERNATIVE BONE FORCEPS. THERE WAS NO KNOWN SURGICAL DELAY NOR PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9036639 ↗
• MalfunctionSep 12, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE REDUCTION FORCEPS BROKE TOWARDS THE TIP. THE ISSUE WAS DISCOVERED AFTER THE CASE. 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 9013765 ↗
• MalfunctionAug 6, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE REDUCTION FORCEPS WITH SERRATED JAW LARGE HANDLE SOFT RATCHET TIP OF THE FORCEPS ACTUALLY BROKE OFF. IT WAS MENTIONED THAT THEY HAD TO TAKE ADDITIONAL IMAGES DURING THE CASE TO FIND THE PIECE THAT BROKE OFF AND IT TOOK AROUND TEN (10) MINUTES TO REMOVE IT. USED A DIFFERENT FORCEPS TO REDUCE THE FEMUR. PROCEDURE COMPLETED FINE. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865779 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT DURING INSPECTION AT THE ORTHO STATION ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE REDUCTION FORCEPS WITH SERRATED JAW WAS BROKEN. THE JAW PORTION WAS BROKEN OFF, MAKING IT UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A REDUCTION FORCEPS W/SERRATED JAW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8629135 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TIP OF THE REDUCTION FORCEPS WITH SERRATED JAW-LARGE HANDLE-SOFT RATCHET BROKE OFF DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE. A BACKUP DEVICE WAS AVAILABLE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF FIVE (5) MINUTES. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596972 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE REDUCTION FORCEPS WITH SERRATED JAW`S LEFT PART OF THE TIP BROKE OFF. PROCEDURE AND PATIENT INVOLVEMENT ARE 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 8388186 ↗
• MalfunctionFeb 12, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE GRASPING PART OF THE REDUCTION FORCEPS WAS DISCOVERED BROKEN. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND SURGICAL INVOLVEMENT. 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 8332969 ↗
• MalfunctionJan 18, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE REDUCTION FORCEPS WAS FOUND TO BE BROKEN BY HOSPITAL STAFF. IT IS UNKNOWN WHEN THE TIP BROKE, BUT IT DID NOT OCCUR DURING SURGERY. THE TIP IS NOT AVAILABLE FOR RETURN. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6260281 ↗
• MalfunctionJan 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE LAST PORTION OF A REDUCTION FORCEPS WITH SERRATED JAW-LARGE HANDLE SOFT RATCHET IS NOT CATCHING PROPERLY. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6255243 ↗