NA 399.092Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982202321), received between Jul 17, 2017 and Aug 19, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT THE SOFT LOCK PART OF THE FORCEPS WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841874 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM HAS BROKEN ON THE HANDLER WHICH CLOSES THE FORCEPS. SURGERY WAS NOT DELAYED DUE TO THE EVENT AND WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872688 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE ITEM BROKE ON THE HANDLER WHICH CLOSES THE FORCEPS. SURGERY WAS NOT DELAYED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872633 ↗
• MalfunctionJul 19, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE FORCEPS WAS RUPTURED. THE BREAKAGE OCCURRED WHEN THE STERILIZER ACCIDENTALLY DROPPED THE PINCER ONTO THE GROUND. NO ADVERSE EVENT REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356064 ↗
• MalfunctionDec 15, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE ORTHOKIT ARRIVED AT THE LOCAL WAREHOUSE WITH A DEVICE BROKE. THIS REPORT IS FOR ONE (1) REDUCT-FORCEPS-LRG W/POINT SOFTLO L222 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990604 ↗
• MalfunctionDec 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP PART OF THE PRODUCT WAS BROKEN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942191 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THE DEPTH GAUGE WAS BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR REDUCTION FORCEPS. THIS IS REPORT 5 OF 5 FOR (B)(4). THIS COMPLAINT IS RELATED TO ANOTHER COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120670 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543915 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543884 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543817 ↗
• 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 SOFT LOCK PART WAS FOUND BROKEN ON AN UNKNOWN DATE. IT WAS UNKNOWN WHEN AND HOW IT WAS OCCURRED. THERE WAS NO PROCEDURE AND PATIENT INFORMATION ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11630238 ↗
• MalfunctionJul 22, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FORCEPS LOCK DEVICE WAS BROKEN AND UNABLE TO HOLD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308457 ↗
• MalfunctionNov 14, 2019Difficult to Open or Close; Difficult to Open or Close

  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 COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9325152 ↗
• MalfunctionJul 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW OF A REDUCTION FORCEPS WITH POINTS FOR FOOT AND ANKLE WAS NOTED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8790056 ↗
• MalfunctionAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS DISCOVERED ON AN UNKNOWN DATE THAT A RATCHET WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7778365 ↗
• MalfunctionApr 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7391802 ↗
• MalfunctionJul 17, 2017Break; Break

  IT WAS REPORTED THAT A REDUCTION FORCEPS WITH POINTS WAS DISCOVERED TO HAVE BROKEN DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE. A TINE HAS BROKEN OFF OF THE FORCEPS (THE DEVICE IS IN TWO PIECES). THERE IS NO ADDITIONAL INFORMATION ANTICIPATED REGARDING THE PROCEDURE OR PATIENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6716938 ↗