NA 03.111.751Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982072573), received between Jan 25, 2019 and Feb 26, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Break; Material Deformation

  IT WAS REPORTED THE CLAMPS BECAME WARPED IN SPD. FORCEPS WERE USED IN THE CASE AND BROKE IN SPD. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455229 ↗
• MalfunctionFeb 26, 2026Break; Material Deformation

  IT WAS REPORTED THE CLAMPS BECAME WARPED IN SPD. FORCEPS WERE USED IN THE CASE AND BROKE IN SPD. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455195 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL RADIUS FRACTURE WITH SOFT TISSUE ATTACHMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, WHEN AN ATTEMPT WAS MADE TO REMOVE THE SOFT TISSUE ATTACHMENT FROM THE FORCEPS, THE ADHESIVE PART BROKE. THERE WAS NO IMPACT ON OPERATIVE TIME OR PATIENTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609427 ↗
• MalfunctionJan 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE SOFT TISS ATTACH J-SHAP F/RED FORCEPS WERE BROKEN AND WORN.

  Patient problems: Insufficient Information

  MAUDE report 21067740 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 20, 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. WHEN THE SOFT TISSUE ATTACHMENT WAS ATTACHED TO THE REDUCTION FORCEPS, A PART OF THE CONNECTION OF THE SOFT TISSUE ATTACHMENT GOT DAMAGED. THE DAMAGE TO THE INSTRUMENT HAS OCCURRED OUTSIDE THE PATIENT'S BODY. THE SALES REP VERBALLY CONFIRMED THAT NO PIECES REMAINED IN THE PATIENT'S BODY AND THAT THE SURGEON WAS NOT INJURED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752379 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THE SOFT TISS ATTACH J-SHAP F/RED FORCEPS WAS FOUND NICKED. THE REPORTED EVENT WAS IDENTIFIED DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RECEIVED DEVICE AT MANUFACTURER'S LOCATION. HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. DURING MANUFACTURER'S FINAL INVESTIGATION OF THE DEVICE ON JUNE 14, 2024 IT WAS IDENTIFIED THAT THE SOFT TISS ATTACH J-SHAP F/RED FORCEPS BROKEN, THE DEVICE SHOWS SOME NICKS. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19542626 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS FURTHER REPORTED THAT THE DAMAGE TO THE INSTRUMENT OCCURRED OUTSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139914 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2024, THE ITEM WAS SENT DOWN TO STERILE PROCESSING WHERE IT THE "J" PIECE OF THE CLAMP GOT SNAPPED OFF AND IS NO LONGER ABLE TO BE USED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/ RED FRCPTHIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961212 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING STERILE PROCESSING THE CLAMP BROKE IN WASH IN SPD. THE EVENT FIND OUT DURING THE FIELD INFECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/ RED FRCP. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803616 ↗
• MalfunctionDec 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY WITH THE VA TCP FOR A DISTAL RADIUS FRACTURE. WHEN THE SOFT TISSUE ATTACHMENT WAS ATTACHED TO THE REDUCTION FORCEPS BALL TIPS, THE MOUNTING PART SHATTERED OUTSIDE THE PATIENT¿S BODY. ALTHOUGH THE SOFT TISSUE ATTACHMENT COULD NOT BE ATTACHED, THE DEVICE WAS USED AS-IS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 2 FOR PC-001496293.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393753 ↗
• MalfunctionOct 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SOFT TISSUE ATTACHMENT BROKE. THIS REPORT INVOLVES ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912556 ↗
• MalfunctionJul 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER THE SURGERY AND BEFORE WASHING, WHEN TRYING TO REMOVE THE ATTACHMENT FROM A FORCEPS SEVERAL TIMES, THE CONNECTION PART OF THE ATTACHMENT BREAKS/CRACKS NO MATTER HOW YOU REMOVE IT. THIS EVENT HAS OCCURRED REGULARLY. THIS REPORT INVOLVES ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379102 ↗
• MalfunctionJul 20, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED DURING DISMANTLING THE ATTACHMENT ON (B)(6) 2023, THE HOLE BROKE. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357293 ↗
• InjuryJul 19, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL RADIUS FRACTURE WITH SOFT TISSUES ATTACHMENT. THIS DEVICE WAS USED IN THE FIXATION OF VA-TCP PLATE. THERE WERE NO PROBLEMS ON THE DAY OF SURGERY, BUT AFTER WASHING THE NEXT DAY, A DEFECT WAS FOUND IN THE CONNECTION AREA UPON EXAMINATION. THE DEFECT IS BEING SEARCHED FOR AND IT IS POSSIBLE THAT IT MAY REMAIN IN THE PATIENT'S BODY. X-RAY CONFIRMATION IS CURRENTLY UNKNOWN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17349769 ↗
• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A DISTAL RADIUS CLAMP WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE CENTRAL PEG WAS BROKEN. THIS REPORT IS FOR A SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761706 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT ON JANUARY 1, 2023, THE TABS WERE BROKEN ON THE J-SHAPED ATTACHMENT SO IT CAN'T CONNECT TO THE REDUCTION FORCEPS. THERE WAS NO PATIENT CONSEQUENCES/OUTCOME. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/ RED FRCP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375814 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE DISASSEMBLING THE SOFT TISSUE CLAMP AT THE METRO OFFICE, THE PLASTIC PIECE BROKE AND WILL NOT WORK CORRECTLY ANYMORE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE SOFT TISSUE ATTCHMT/J-SHAPED F/ RED FRCP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056948 ↗
• MalfunctionDec 20, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PRODUCT IN QUESTION FOR THE PLANNED SURGERY THE NEXT DAY HAD BEEN DAMAGED. SUBSTITUTE PRODUCTS WERE URGENTLY ORDERED TO COMPLETE THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014272 ↗
• MalfunctionJul 19, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CLIP FOR THE DISTAL RADIUS CLAMP BROKE OFF ON THE BACK TABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053783 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THE REDUCTION FORCEPS WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT (SPD). IT WAS NOT BROKEN DURING SURGERY BUT FOUND THIS WAY IN SPD. THIS REPORT IS FOR A REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488002 ↗
• MalfunctionMay 19, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THERE WAS A CHIP IN THE RESIN MATERIAL OF THE PRODUCT AT THE TIME OF INSPECTION WHEN THE PRODUCT WAS DELIVERED TO THE HOSPITAL. THIS EVENT OCCURRED ON THE DAY BEFORE SURGERY, AND THE SALES REPRESENTATIVE RE-ARRANGED THE PRODUCT. ON (B)(6), 2022, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION FOR FRACTURE OF THE DISTAL RADIUS. THE SURGERY WAS COMPLETED WITH NO DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR A SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438145 ↗
• MalfunctionMar 22, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING POST SURGICAL INSPECTION OF BONE REDUCTION FORCEPS IN STERILE PROCESS ROOM, IT WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOFT TISS ATTACH J-SHAP F/REDUC FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13846077 ↗
• MalfunctionMar 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY. IN THE SURGERY, A PETITE FEMALE STAFF TRIED TO ATTACH THE SOFT TISSUE ATTACHMENT TO A REDUCTION FORCEPS WITH BALL TIPS, BUT SHE COULDN¿T. THEREFORE, THE SOFT TISSUE ATTACHMENT WAS CHECKED, AND IT WAS FOUND THAT THE CONNECTING PART OF THE SOFT TISSUE ATTACHMENT WAS BROKEN. IT BROKE DUE TO THE FORCE APPLIED TO BE ATTACHED. THE PROCEDURE WAS PROCEEDED WITHOUT USING THE SOFT TISSUE ATTACHMENT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SOFT TISS ATTACH J-SHAP F/REDUC FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792804 ↗
• MalfunctionMar 7, 2022Break; Break

  IT WAS REPORTED THAT PIECE OF ITEM BROKE WHEN ATTACHING. THIS COMPLAINT INVOLVES ONE (1) DEVICE .SOFT TISSUE ATTCHMT/J-SHAPED F/ RED FRCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685370 ↗
• MalfunctionApr 29, 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 OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL RADIUS FRACTURE WITH THE SOFT TISSUE ATTACHMENT IN QUESTION. DURING THE SURGERY, SURGEON WAS ADJUSTING THE CONNECTION BETWEEN THE FORCEPS AND THE SOFT TISSUE ATTACHMENT BROKE. THE SURGEON ATTEMPTED THE USUAL PROCEDURE UNDER THE BROKEN CONDITION. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE FRAGMENTS WERE COLLECTED AND NO FRAGMENTS WERE LEFT IN THE BODY. THERE WAS DEGRADATION, DUE TO EXCESSIVE STRESS ON THE PRODUCT AND FREQUENT USE IS ALSO SUSPECTED AS THE CAUSE OF DAMAGE. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745190 ↗