NA 397.706Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982201072), received between Dec 21, 2020 and Jan 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223836 ↗
• MalfunctionSep 25, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT A TORQUE LIMITER AND HANDLE FOR TORQUE LIMITER BROKE. NO PATIENT WAS AFFECTED BUT LOCKING MECHANISM IN HANDLE IS NOT WORKING. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) HANDLE FOR AO REAMING COUPLER CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813971 ↗
• MalfunctionSep 16, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A TORQUE LIMITER WAS FOUND DAMAGED PRE-OPERATIVELY ON (B)(6) 2022. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR HANDLE FOR AO REAMING COUPLER CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438415 ↗
• MalfunctionFeb 2, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PEPROPROSTHETIC FRACTURE, THE TWO INSTRUMENTS DID NOT WORK ADEQUATELY BECAUSE THEY WERE BROKEN. THERE WAS NO SURGICAL DELAY REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) HANDLE FOR AO REAMING COUPLER CONNECTION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268788 ↗
• MalfunctionDec 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATE: DEVICE REPORT FROM SLOVAKIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE PRE-OP, DURING TESTING FOR THE DEVICE, THAT HANDLE WOULD NOT HOLD THE TORQUE LIMITER. THE PROCEDURE WAS COMPLETED, WITH A ALTERNATIVE DEVICE THAT WAS USED. THIS REPORT IS FOR ONE (1) HANDLE FOR AO REAMING COUPLER CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4) DURING PROCEDURE: HOW WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046290 ↗