NA 321.15Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982190383), received between Mar 29, 2021 and May 4, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT THE PIVOT HINGE BROKE DURING TIGHTENING PHASE. REPLACEMENT WRENCH WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071108 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE ARTICULATING WRENCH BROKE APART WHEN USING IT DURING THE CASE. A SECOND SET WAS OPENED IN ORDER TO FINISH THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267965 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, A NAIL WAS INSERTED. WHILE INSERTING SCREWS, THE T-HANDLE KEPT DISENGAGING FROM THE SHORT POWER SHAFT, AND THE INNER CONNECTING ELEMENT BROKE FROM MALLETING. DRIVER 03.045.003 AND RETENTION PIN 03.045.004 ALSO STRIPPED/BROKE IN THE PROCESS OF TIGHTENING THE SCREW WHILE MALLETING. AFTER NAILING, A VA PPFX PROXIMAL FEMUR PLATE WAS POSITIONED DUE TO THE NAIL. THE SCREW INSERTED WITH THE CANNULATED HEX DRIVER WAS STRIPPED DUE TO THE TORQUE OF THE SCREWDRIVER. A HANDLE SWIVEL WRENCH WAS ALSO USED WITH THE ARTICULATING TENSION DEVICE; TWO BROKE OFF DUE TO PRESSURE, SO A SOLID ONE WAS USED INSTEAD. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. CONCOMITANT PRODUCT DETAILS: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN), UNK - PLATES: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN) THIS REPORT IS FOR ONE (1) SOCKET WRENCH Ø 11.0 MM THIS IS REPORT 7 OF 9 FOR COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869717 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, A NAIL WAS INSERTED. WHILE INSERTING SCREWS, THE T HANDLE KEPT DISENGAGING FROM THE SHORT POWER SHAFT AND THE INNER CONNECTING ELEMENT BROKE FROM MALLEATING. AFTER NAILING A VA PPFX PROXIMAL FEMUR PLATE WAS POSITIONED, DUE TO THE NAIL. THE SCREW INSERTED WITH THE CANNULATED HEX DRIVER WAS STRIPPED DUE TO TORQUEING SCREWDRIVER. A T-HANDLE SWIVEL WRENCH WAS ALSO USED WITH THE ARTICULATING TENSION DEVICE, TWO BROKE OFF DUE TO PRESSURE SO A SOLID ONE WAS USED INSTEAD. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) SOCKET WRENCH Ø 11.0 MM. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865105 ↗
• MalfunctionAug 17, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY IT WAS NOTICED THAT THE WRENCH IS BROKEN. NO PATIENT INVOLVEMENT .NO FURTHER INFORMATION AT THIS TIME. THIS REPORT IS FOR ONE (1) SOCKET 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 15242973 ↗
• 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) SOCKET WRENCH-11MM WIDTH ACROSS FLATS . THIS REPORT IS 6 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196351 ↗
• MalfunctionDec 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE REVISION OF THE RIGHT TOTAL HIP, A T HANDLE REMOVAL DEVICE CAME APART INTO THE WOUND. ALL VISIBLE PIECES WERE REMOVED AND SEQUESTERED. X-RAYS WERE OBTAINED INTRA-OP AND WERE NEGATIVE FOR RETAINED OBJECTS. NO INJURY WAS NOTED TO THE PATIENT. A SLIGHT SURGICAL DELAY OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SOCKET WRENCH-11MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 OR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961840 ↗
• MalfunctionMar 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE INSTRUMENT BROKE DURING CLAMP REMOVAL. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) SOCKET WRENCH-11MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581563 ↗