NA 03.010.496Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982069139), received between Mar 13, 2023 and Sep 18, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.

• MalfunctionSep 18, 2026Crack

  It was reported that the Sterilising department processing consignment advanced nail set - and found T handle had a slit / split in blue silicone handle. Not suitable for re-sterilising. There were no patient consequences. Upon manufacturers investigation it was noted that the instrument was chipped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817347 ↗
• MalfunctionFeb 12, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE OLIVE-SHAPED GUIDE WAS BENT DUE TO MANIPULATION AND THE SHAPE OF THE FRACTURE. ADDITIONALLY, THE T-HANDLE WAS DAMAGED, CAUSING IT TO MALFUNCTION BECAUSE IT JAMS AND IS TOO STIFF WHEN OPENING AND CLOSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324822 ↗
• MalfunctionJan 22, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, THE REDUCTION TOOL WAS SLIPPERY WHEN THE SURGEON ATTEMPTED TO USE IT. THE SURGEON DISCONTINUED USE OF THE TOOL AND SENT IT TO THE CENTRAL STERILE SUPPLY DEPARTMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT. SUBSEQUENT REVIEW BY THE CSSD STAFF SUGGESTED THAT LUBRICANT FROM THE HEXAGONAL T-HANDLE CONNECTED TO THE REDUCTION TOOL MAY HAVE LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144193 ↗
• MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE HOSPITAL REPORTED THAT ON (B)(6) 2025, THERE WAS A PROBLEM WITH THE CONNECTION BETWEEN THE PRODUCTS IN QUESTION USED FOR THE SURGERY. THE PRODUCTS IN QUESTION WERE NOT USED CLINICALLY AND DID NOT AFFECT THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363736 ↗
• MalfunctionAug 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLES ARE NOT ATTACHING TO DRIVER ON AN UNKNOWN DATE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805954 ↗
• MalfunctionAug 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLES ARE NOT ATTACHING TO DRIVER ON AN UNKNOWN DATE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805837 ↗
• MalfunctionMay 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  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) T-HANDLE CANN W/QUICK-COUPL HEX12 THIS IS REPORT 6 OF 9 FOR COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869888 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  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. 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) T-HANDLE CANN W/QUICK-COUPLE HEX12 THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865103 ↗
• MalfunctionMar 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL SLEEVE WAS BENT BEYOND BEING ABLE TO USE. THE TORQUE LIMITING ATTACHMENT WAS AGAIN BENT AND NOT ABLE TO CONNECT TO SHAFT. THE AIMING ARM WAS CRACKED IN CARBON FIBER AND THE T HANDLE WOULD NOT CONNECT PROPERLY TO QUICK CONNECT ATTACHMENT FOR THE HANDLE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T-HANDLE/CANNULATED WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530142 ↗