NA 392.969Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982198921), received between Dec 29, 2016 and Dec 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING A PROCEDURE IT WAS NOTED THAT THE T-HANDLE WRENCH FOR MEDIUM EXTERNAL FIXATOR BROKE WHILE APPLYING CLAMPS FOR AN EX-FIX FRAME. A RATCHET WRENCH WAS USED INSTEAD OF T-HANDLE WRENCH TO COMPLETE THE PROCEDURE. THERE WERE FRAGMENTS GENERATED BUT REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES NOTED. THIS REPORT INVOLVES ONE (1) COMBINATION T-WRENCH 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919320 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE COMBINATION T-WRENCH 8MM WAS BROKEN AT THE T INTERSECTION OF THE TWO PIECES. THE SURGEON USED THE OTHER COMBINATION WRENCH THAT WAS IN THE SET TO FINISH THE CASE. THERE WAS UNKNOWN SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) COMBINATION T-WRENCH 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173881 ↗
• MalfunctionDec 29, 2016Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2016, A COMBINATION T-WRENCH 8MM WAS FOUND BROKEN IN THE STORAGE FACILITY. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) COMBINATION T-WRENCH 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6212489 ↗