NA 03.211.400Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982076267), received between Feb 23, 2017 and Sep 26, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT THE CLAMPS BROKE. NO OPERATION WAS INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312994 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT THE CLAMPS BROKE. NO OPERATION WAS INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION TO REPORT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312980 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 3, 2024 THE PRODUCT WAS BROKEN AND NOT USABLE. THERE WAS NO PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559915 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THAT A SPRING BROKE ON THE INSTRUMENT HANDLE OF COMPRESSION FORCEP. THE PATIENT'S PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUES REGARDING THE PATIENT. THIS REPORT IS FOR ONE (1)COMPR-FORCEPS F/USE WITH COMPR WIRE . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881158 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INTRA-OP DISCOVERY OF BROKEN SPRING IN HANDLE OF COMPRESSION FORCEP. SURGEON WAS ABLE TO MAKE INSTRUMENT WORK AND COMPLETE CASE SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878374 ↗
• MalfunctionNov 29, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING POST-OP EVENT A CENTRAL PROCESSING TECHNICIAN WAS NOTICED THAT COMPR-FORCEPS F/USE WITH COMPR WIRE BROKEN AT THE JOINT CONNECTING THE PLIERS THE RATCHETED PATH. THEY BELIEVED THAT THE WELDING POINT WAS MINIMAL AND SEPARATED DUE TO QUALITY. THERE WAS NO PATIENT EXPERIENCE POST-OP DEVICE MALFUNCTION. PATIENT DID NOT REQUIRE ANY REVISION SURGERY. THERE WAS NO PATIENT INVOLVEMENT AND PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) COMPR-FORCEPS F/USE WITH COMPR WIRE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882495 ↗
• MalfunctionJun 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT DURING ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY THE CONSULTANT NOTICED THAT COMPRESSION ARM IS BROKEN OFF. NO PATIENT INVOLVEMENT AND I HAVE NO FURTHER INFORMATION AT THIS TIME. THIS COMPLAINT INVOLVES ONE (1) DEVICE COMPR-FORCEPS F/USE WITH COMPR WIRE. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852587 ↗
• MalfunctionJun 22, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE CLAMP BROKE. PATIENT INVOLVEMENT WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775890 ↗
• MalfunctionOct 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE COMPRESSION FORCEPS RATCHET MECHANISM DID NOT FUNCTION CORRECTLY. THE SURGEON IMPROVISED AND MADE IT WORK. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DURING MANUFACTURER'S INVESTIGATION IT WAS IDENTIFIED THAT DEVICE HAS SOME WEAR ON THE TEETH OF THE RATCHET MECHANISM. THERE WAS ALSO A CHIP OF MATERIAL MISSING FROM THE SMALL FLAP. THIS REPORT IS FOR (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701147 ↗
• MalfunctionJun 18, 2021Break; Break

  IT WAS REPORTED THAT, WHILE REPLACING PARTS TO STERILIZE THE TRAY, IT WAS NOTED THAT THE COMPRESSION FORCEPS HAS A TAG ON IT SAYING BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028770 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN THE STERILE PROCESSING DEPARTMENT THE FORCEPS WERE FOUND WITH A BROKEN SPRING. THE TRAY WAS TAGGED AS BROKEN. THIS REPORT INVOLVES 1 COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272659 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COMPRESSION FORCEPS WAS BROKEN, IT WAS DISCOVERED BEFORE THE CASE STARTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 1 COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11027766 ↗
• MalfunctionApr 17, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION OF COMPRESSION INSTRUMENT ON MARCH 25, 2020, THE COMPRESSION FORCEPS WAS NOTICED TO BE BROKEN AND UNUSABLE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9972194 ↗
• MalfunctionMar 16, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A LISFRANC PROCEDURE THAT IT WAS DISCOVERED THAT THERE WERE TWO BROKEN INSTRUMENTS. ONE (1) FROM A LOCKING COMPRESSION PLATE (LCP) MINI FRAGMENT SET AND THE OTHER (1) FROM A VARIABLE (VA) FOREFOOT/ MIDFOOT SET. THERE WERE NO FRAGMENTS GENERATED FORM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE COMPRESSION FORCEPS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835086 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A FORCEPS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812878 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCREW HOLDING THE TWO PIECES TOGETHER OF THE COMPRESSION FORCEP CAME OUT DURING CLEANING PROCESS. DURING INSPECTION OF THE PRODUCT FOR RESTOCK, THE TENSION BAR BROKE AT A RUSTY SPOT AT A POINT WHERE IT WAS ATTACHED BY A SEPARATE SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9616396 ↗
• MalfunctionOct 24, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TARSO-METATARSAL FUSION PROCEDURE AND THE PROCESS OF APPLYING COMPRESSION TO THE COMPRESSION WIRES IN THE 2.7 VA FOREFOOT/MIDFOOT SET, ONE OF THE ARMS OF THE COMPRESSION FORCEPS SNAPPED OFF. THERE WERE FRAGMENTS GENERATED AND WERE REMOVED EASILY. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES TO GET BACK UP INSTRUMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN 2.7 VARIABLE ANGLE (VA) PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN WIRES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) COMPRESSION FORCEPS. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9235001 ↗
• MalfunctionJan 31, 2019Break; Break

  IT WAS REPORTED THAT DURING A METATARSOPHALANGEAL JOINT FUSION PROCEDURE ON (B)(6) 2019, THE RATCHET PART OF THE COMPRESSION FORCEPS DID NOT OPERATE AND WILL NOT HOLD COMPRESSION. THE SURGEON HAD TO MANUALLY CONTINUE TO HOLD THE PRESSURE INSTEAD OF USING THE FORCEPS. FRAGMENTS WERE GENERATED AND WAS SUCCESSFULLY REMOVED. THERE WAS NO SURGICAL DELAY. SURGERY WAS SUCCESSFULLY COMPLETED. NO UNANTICIPATED X-RAYS WERE NEEDED. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293489 ↗
• MalfunctionDec 27, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE FIELD INSPECTION OF THE INSTRUMENT, THE COMPRESSION FORCEPS WERE DISCOVERED AS BROKEN. THE RATCHETING DEVICE WAS BROKEN JUST ABOVE THE SCREW THAT ATTACHES TO THE HANDLE. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8199585 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT A COMPRESSION FORCEPS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVE ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8090701 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT A RETURNED COMPRESSION FORCEPS FROM FSL FACILITY WAS NOTED AS ¿NOT LOCKING¿. THE DEVICE WAS INSPECTED AS PART OF THE ROUTINE INCOMING INSPECTION ON (B)(6) 2018. THE FORCEPS WAS BEING OUT OF SPECIFICATION. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. UPON INSPECTION IT WAS NOTICED THAT A PIECE OF THE SMALL FLAP HAD CHIPPED OFF AND CONTRIBUTED TO THE COMPLAINT CONDITION. THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7929755 ↗
• MalfunctionApr 24, 2017Break; Break

  IT WAS REPORTED THAT WHILE SETTING UP FOR AN INITIAL TARSOMETATARSAL (TMT) ARTHRODESIS PROCEDURE ON (B)(6) 2017, THE SCRUB TECH DISCOVERED THAT THE SPRING IN THE COMPRESSION FORCEPS THAT ALLOWS THE DEVICE TO OPEN IS BROKEN BUT STILL ATTACHED TO THE FORCEPS. NO ISSUES WITH THE DEVICE PRIOR TO DISCOVERY. IT IS UNKNOWN HOW LONG THE DEVICE HAS BEEN IN USE. A BACKUP FORCEPS WAS OFFERED TO THE SURGEON. HOWEVER, SURGEON CONTINUED TO USE THE DEFECTIVE FORCEPS IN SURGERY. THE FORCEPS WERE USED OVER THE PATIENT TO COMPRESS AGAINST TWO COMPRESSION WIRES. THERE WERE NO FRAGMENTS GENERATED. STANDARD X-RAYS TAKEN DURING PROCEDURE CONFIRM THERE WERE NO FRAGMENTS IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT REQUIRING MEDICAL INTERVENTION. NO SURGICAL DELAY REPORTED. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: WIRES (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) COMPRESSION FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6515899 ↗
• MalfunctionMar 9, 2017Break; Break

  IT WAS REPORTED BY SERVICE AND REPAIR DEPARTMENT THAT SYNTHES EVALUATION EQUIPMENT-THE COMPRESSION FORCEPS HAS A BROKEN LEAF SPRING. THE ISSUE WAS IDENTIFIED DURING INSPECTION ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6393107 ↗
• MalfunctionMar 1, 2017Failure To Adhere Or Bond; Material Fragmentation; Failure To Adhere Or Bond; Material Fragmentation

  IT WAS REPORTED THAT DURING A FIRST MTP (METATARSOPHALANGEAL) JOINT FUSION THE COMPRESSION FORCEPS MALFUNCTIONED. WHILE USING THE DEVICE IT DID NOT HOLD IN THE COMPRESSION MODE, THE SWITCH WAS NOT WORKING AS INTENDED. THE PHYSICIAN ASSISTANT HAD TO MANUALLY HOLD THE FORCEPS IN PLACE. THERE WAS A MINIMAL DELAY OF APPROXIMATELY FIVE (5) MINUTES. THERE WAS NO PATIENT HARM AND PATIENT IS REPORTED AS BEING STABLE. WHILE THE RETURNED DEVICE WAS BEING INVESTIGATED, IT WAS NOTED THAT THE RETURNED COMPRESSION FORCEPS WERE FOUND TO HAVE WEAR TO THE TEETH OF THE RATCHETING RAIL. THE FLAP WAS FOUND TO BE BROKEN WITH A FRAGMENT MISSING WHERE IT CONTACTS THE RATCHETING RAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6367599 ↗
• MalfunctionFeb 23, 2017Break; Break

  IT WAS REPORTED THAT THE SURGEON HAD TO MANUALLY HOLD THE COMPRESSION FORCEPS SHUT DURING A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) PROCEDURE (B)(6) 2017 BECAUSE THEY WOULD NOT LOCK. COMPRESSION WAS ACHIEVED AND THE CASE WAS SUCCESSFUL. ONCE THEY WERE PULLED FROM THE FIELD IT BECAME CLEAR THE INNER THIN CONNECTION PIECE THAT IS PARALLEL TO THE HANDLE BROKE AT THE JUNCTION OF THE CONNECTION PIECE AND THE SCREW. THE CASE WAS SUCCESSFUL, THERE WAS NO DELAY AND NO INFORMATION ON PATIENT OUTCOME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6353255 ↗