NA 03.037.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10886982070463), received between Feb 1, 2017 and Sep 30, 2026 — classified as 10 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Break” (63 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); they may or may not involve this specific model.

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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  It was reported that the Driving Cap f/Insertion Handle, Multihole Drill Sleeve, Trocar yell, ScrDriver-hex 5 flex cann, Extract-Instr f/TFNA Helical Blade+Scr, ScrDriver short XL25, ScrDriver w/Quick-Coupl hex 12 short XL2, Hand lrg cann w/Quick-Coupl Hex12, ConnecScr f/TFNA Helical Blade+Scr, and ScrDriver Shaft self-holding L165 f/Star were associated with wear-related and deformation issues. The reported failures included stripped or worn threads that did not engage securely, deformed holes that made guide wire passage difficult, a bent trocar that did not fit the cannula properly, dull screwdriver features that did not seat securely or function properly, and a handpiece that no longer clicked into screwdriver shafts. There was no patient involvement. The complaint devices were retained by the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946022 ↗
• MalfunctionSep 22, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856502 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776487 ↗
• MalfunctionSep 15, 2026Break

  It was reported that on an unknown date, the tip of the extractor broke off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775535 ↗
• MalfunctionSep 8, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674825 ↗
• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT TIP OF THE TFNA LAG SCREW/ HELICAL BLADE EXTRACTOR BROKE OFF WHEN TAKING IT OFF THE LAG SCREW AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536548 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT THE TFNA LAG SCREW / HELICAL BLADE EXTRACTOR TIP BROKE OFF WHEN TAKING IT OFF THE LAG SCREW AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458183 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT THE HELICAL BLADE/SCREW EXTRACTOR BROKE ON A HARDWARE REMOVAL CASE ON (B)(6) 2026 DURING HELICAL BLADE REMOVAL. THE PATIENT WAS NOT HARMED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH LITTLE TO NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360225 ↗
• MalfunctionApr 15, 2026Device-Device Incompatibility

  IT WAS REPORTED A LAG SCREW WAS RETAINED ON LAG SCREW EXTRACTION AFTER REVISION SURGERY.UNABLE TO REMOVE IMPLANT FROM INSTRUMENT. NO PATIENT HARM; NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887744 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT THE END OF THE EXTRACTION TOOL WAS BROKEN OFF. SURGICAL DELAY WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582567 ↗
• MalfunctionMar 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE HELICAL BLADE/SCREW EXTRACTOR AND PUSH-PULL RED DEVICE WERE DAMAGED AFTER USE IN SURGERY. THE HELICAL BLADE/SCREW EXTRACTOR WAS FOUND TO HAVE STRIPPED THREADS, WHILE THE PUSH-PULL RED DEVICE WAS DESCRIBED AS BADLY DAMAGED. BOTH DEVICES WERE AVAILABLE FOR RETURN, AND REPLACEMENTS WERE REQUESTED. THERE WAS NO PATIENT HARM OR SURGICAL INTERVENTION REQUIRED, AND NO SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578631 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HELICAL BLADE/SCREW EXTRACTOR HAD A DAMAGED T-HANDLE THAT BECAME LOCKED ONTO THE EXTRACTOR AND COULD NOT BE REMOVED DURING THE EXTRACTION OF A BLADE FROM THE FEMUR IN A HARDWARE REMOVAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL CONSEQUENCE, AS THE ISSUE WAS LIMITED TO THE DEVICE INTERACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556992 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED DEPTH GAUGES WERE BENT AND COULD NOT BE USED FOR ACCURATE MEASUREMENT, LENGTH INDICATORS ON SCREW CADDIES WERE COMING OUT MAKING IT DIFFICULT TO QUICKLY FIND THE CORRECT SCREW LENGTH, AND THREADS ON THE TFNA LAG SCREW EXTRACTOR WERE STRIPPED. THESE ISSUES WERE DISCOVERED WHEN TRAYS WERE BEING REASSEMBLED AFTER CASES; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518819 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED DEPTH GAUGES WERE BENT AND COULD NOT BE USED FOR ACCURATE MEASUREMENT, LENGTH INDICATORS ON SCREW CADDIES WERE COMING OUT MAKING IT DIFFICULT TO QUICKLY FIND THE CORRECT SCREW LENGTH, AND THREADS ON THE TFNA LAG SCREW EXTRACTOR WERE STRIPPED. THESE ISSUES WERE DISCOVERED WHEN TRAYS WERE BEING REASSEMBLED AFTER CASES; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518772 ↗
• 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 24279883 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THE INSTRUMENT WAS BROKEN DURING A TFNA REMOVAL. TFNA WAS BEING REMOVED SO PATIENT COULD GET A TOTAL HIP. THE TIP WAS BROKEN OFF. THERE WAS DIFFICULTY GETTING THE IMPLANT REMOVED AS A RESULT. THE THREAD WAS BROKEN MEANING THE LENGTH THAT WAS LEFT WASN¿T ENOUGH TO GET THE LAG SCREW OUT. ANOTHER INSTRUMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 TO 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192140 ↗
• MalfunctionNov 26, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE ITEM WAS RECEIVED DIRTY AND DAMAGED. THERE WAS NO PATIENT CONSEQUENCE; THE PROCEDURE TOOK PLACE AS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657114 ↗
• MalfunctionSep 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT THE DEVICE IS DAMAGED. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE TIP OF THE EXTRACT-INSTR F/TFNA HELICAL BLADE+SCR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993393 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENT CAN NO LONGER BE GUIDED THROUGH THE INSERTION HANDLE TO LOCK THE NAIL. EVENT WAS NOTED AS PRE-OP, DURING PRODUCT/SYSTEM INSTRUCTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860424 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TWO INSTRUMENTS (03.037.032 & 03.037.030) COLD WELDED TO IMPLANT DURING EXTRACTION/REMOVAL PROCEDURE. UNABLE TO REMOVE FROM BROKEN IMPLANT. PROCEDURE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860067 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT THE SLAP-HAMMER CONNECTION END OF THE SCREW/BLADE EXTRACTOR WAS NOTICED AS DAMAGED POST-OPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309447 ↗
• MalfunctionApr 2, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEVICE BROKE DURING A TFNA HARDWARE REMOVAL. HARDWARE WAS REMOVED PER SURGEON PREFERENCE. NOT ALL PIECES OF BROKEN INSTRUMENT WERE REMOVED, THEY WERE LODGED INSIDE THE LAG SCREW AND UNABLE TO BE RETRIEVED. SURGERY WAS NOT COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21751390 ↗
• MalfunctionFeb 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, THE EXTRACTOR THREADS WERE WORN DOWN. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354478 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT THE EXTRACTOR TIP WAS BROKEN OFF. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354353 ↗
• MalfunctionJan 31, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE TFNA NAIL REMOVAL SURGERY, THE TIP OF THE INSTRUMENT BROKE WHILE TRYING TO REMOVE THE TFNA SCREW WHICH WAS STUCK IN THE BONE. THE BROKEN INSTRUMENT TIP WAS LEFT INSIDE THE TFNA SCREW WHICH WAS LEFT INSIDE THE PATIENT WITHOUT REMOVAL. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21288232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. One submission often covers many models, so check the product and lot details in each record.

• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima