NA 321.20Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982190444), received between Feb 27, 2020 and Dec 1, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE ARTHREX PULLED A LARGE EXFIX SET TO USE AND 2 RATCHETING WRENCHES WERE BROKEN DURING CASE TRYING TO REMOVE AN EXFIX. THEN THE MANUAL WRENCH WAS USED WHICH WAS KEPT AS A BACKUP IN THE HOUSE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCES BUT A SLIGHT DELAY DURING CASE BUT NOTHING SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679043 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE ARTHREX PULLED A LARGE EXFIX SET TO USE AND 2 RATCHETING WRENCHES WERE BROKEN DURING CASE TRYING TO REMOVE AN EXFIX. THEN THE MANUAL WRENCH WAS USED WHICH WAS KEPT AS A BACKUP IN THE HOUSE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCES BUT A SLIGHT DELAY DURING CASE BUT NOTHING SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679014 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT FOUND A COUPLE BROKEN INSTRUMENTS. THE SALES ASSOCIATE WAS UNSURE AS TO HOW OR WHEN THE INSTRUMENTS BROKE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) RATCHET WRENCH-11MM WIDTH ACROSS FLATS. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18702810 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023, THE RATCHET BROKE DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE RATCHET WRENCH-11MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266011 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS TIGHTENING EX FIX CLAMP WITH WRENCH WHEN RATCHETING MECHANISM BROKE. USED DIFFERENT WRENCH IN SET. NO FRAGMENTS WERE GENERATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - EX-FIX CLAMPS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) RATCHET WRENCH-11MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15449325 ↗
• MalfunctionJun 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, RATCHETING WRENCH FOR THE LARGE EXTERNAL FIXATION SET BROKE DURING SURGERY. IT WOULD NOT TIGHTEN THE NUTS ON THE LARGE COMBINATION CLAMPS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE RATCHET WRENCH-11MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854370 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PRODUCTS FOUND BROKEN AFTER SURGERY AND ARE BEYOND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT IS FOR (1) RATCHET WRENCH-11MM WIDTH ACROSS FLATS. THIS REPORT IS 10 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196384 ↗
• MalfunctionMay 25, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RATCHET WRENCH AND THE UNIVERSAL BENDING PLIERS WERE BROKEN. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT OR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877930 ↗
• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT WAS GIVEN A BROKEN ITEM BY STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9765771 ↗