NA 399.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982202291), received between Mar 6, 2023 and Sep 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 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 UNKNOWN SURGERY FOR A PATELLAR FRACTURE. DURING SURGERY, THE PATELLA FORCEPS BROKE OFF AT ABOUT 10 MM FROM THE TIPS. THE SURGEON WAS NOT AWARE OF ANY UNREASONABLE USE OF THE PATELLA FORCEPS AND WAS USING THEM IN THE NORMAL WAY, BUT THEY BROKE OFF. THE PATELLA FORCEPS WERE PURCHASED ON AUGUST (B)(6) 2023, AND USED FOR THE FIRST TIME AFTER PURCHASING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FRAGMENTS WERE RETAINED AND THIS WAS CONFIRMED BY X-RAY. PATIENT LISTED AS STABLE. THIS REPORT IS FOR ONE PATELLA FORCEPS-SOFT RATCHET FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699347 ↗
• MalfunctionAug 29, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A PATELLA FRACTURE. DURING SURGERY, THE TIP OF THE FORCEPS BROKE OFF. THE FORCEPS WAS USED FOR THE FIRST TIME AFTER PURCHASED AT THE BEGINNING OF (B)(6). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PATELLA FORCEPS-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642427 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A TRAINING PROCEDURE ON A CADAVER ON AN UNKNOWN DATE, THE SURGEON ATTEMPTED TO COMPRESS A FRACTURE OF THE HUMERAL CONDYLE, AND THE CLAMP BROKE. THIS REPORT IS FOR A PATELLA FORCEPS-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811443 ↗
• MalfunctionMar 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 10, 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH THE FORCEPS FOR THE PATELLAR FRACTURE. THE TIP OF THE FORCEPS WAS BROKEN OFF DURING FIRST USE WHICH WAS PURCHASED IN JANUARY 2023. ANOTHER FORCEPS WITH A WEAKER LOCKING WAS USED FOR SURGERY WHICH WAS PURCHASED IN 2014. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PATELLA FORCEPS-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486252 ↗