NA 03.037.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982070470), received between Mar 20, 2020 and Sep 22, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858597 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE WRENCH BROKE DURING THE TIGHTENING PHASE. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399236 ↗
• MalfunctionMar 31, 2026Break

  THE PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746241 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE HELICAL LADE SCREW EXTRACTOR AND COMBINATION WRENCH 11MM/BLADE SCREW HAVE BROKEN AFTER REMOVAL OF A LAG SCREW FROM TFNA POST-OPERATIVELY, DURING AN ATTEMPT TO REMOVE THE LAG SCREW FROM THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279865 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT THE WRENCH SNAPPED AFTER TRYING TO REMOVE A BLADE FROM THE BLADE REMOVAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24181522 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THE WRENCH BROKE WHEN USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122043 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT TNA DRIVE CAP PIN CAME OUT WHEN MALLETING. VOLT BLUE HANDLE BROKE WHEN COUNTERSINKING. 11MM WRENCH BROKE WHEN TIGHTENING RFNA CAP. ALSO HAD TWO 2.5MM HEX STRIP AND TWO MEDIUM LOBSTER CLAW SPINDLE BENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059620 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT TNA DRIVE CAP PIN CAME OUT WHEN MALLETING. VOLT BLUE HANDLE BROKE WHEN COUNTERSINKING. 11MM WRENCH BROKE WHEN TIGHTENING RFNA CAP. ALSO HAD TWO 2.5MM HEX STRIP AND TWO MEDIUM LOBSTER CLAW SPINDLE BENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059619 ↗
• MalfunctionMar 28, 2025Break; Material Deformation; Break; Material Deformation

  TIP OF KEYS BROKE WHEN TORQUE WAS APPLIED. END OF WRENCHES WERE TORN APART. THE SURGERY WAS DELAYED 5 MINUTES. A REPLACEMENT KEY WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720531 ↗
• MalfunctionMar 28, 2025Break; Material Deformation; Break; Material Deformation

  TIP OF KEYS BROKE WHEN TORQUE WAS APPLIED. END OF WRENCHES WERE TORN APART. THE SURGERY WAS DELAYED 5 MINUTES. A REPLACEMENT KEY WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720319 ↗
• MalfunctionNov 11, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT HAPPENED DURING POST-OP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654068 ↗
• InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024, A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20439780 ↗
• MalfunctionJun 14, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT A WRENCH HEX 11/BLADE-SCREW BROKE INTRA-OPERATIVELY. NO OTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) COMBINATION WRENCH 11MM/BLADE SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123616 ↗
• MalfunctionMay 22, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975697 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET THE WRENCH, HEXAGONAL SOCKET 11/BLADE-SCREW WAS OBSERVED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMBINATION WRENCH 11MM/BLADE SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759991 ↗
• MalfunctionJan 12, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT, WHILE TAKING THE IMPLANT OFF THE HELICAL BLADE/SCREW EXTRACTOR WAS STRIPPED AND WILL NOT DETACH FROM THE SCREW. THE COMBINATION WRENCH WAS BROKEN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) COMBINATION WRENCH 11MM/BLADE SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237346 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 AFTER AN UNKNOWN PROCEDURE, THE HELICAL BLADE WAS STILL ON THE INSERTED. WHEN USING THE COMBINATION WRENCH TO SEPARATE THE IMPLANT FROM THE INSTRUMENT, THE ARMS OF THE COMBINATION WRENCH SNAPPED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) COMBINATION WRENCH 11MM/BLADE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923890 ↗
• MalfunctionJul 26, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INSPECTION IT WAS OBSERVED THAT THE COMBINATION WRENCH WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A COMBINATION WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225633 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE RETURNED TO THE FACILITY BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) COMBINATION WRENCH 11MM/BLADE SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648766 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2021, WHILE THE OPERATING ROOM STAFF WAS TRYING TO TAKE THE INSTRUMENT APART WITH THE WRENCH, THE WRENCH BROKE. THE PROCEDURE WAS OVER WHEN EVENT HAPPENED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) AND UNKNOWN TFNA EXTRACTION DRIVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)COMBINATION WRENCH 11MM/BLADE SCREW. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578622 ↗
• MalfunctionMar 20, 2020Break; Break

  IT WAS REPORTED THAT ON JANUARY 25, 2020 AT THE STERILE PROCESSING, THE WRENCH BROKE WHILE TRYING TO DISENGAGE THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) HELICAL BLADE FROM EXTRACTOR. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN EXTRACTOR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9859730 ↗