NA 03.037.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982070395), received between Apr 18, 2018 and Sep 14, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent

  It was reported several instruments were found broken, stripped, and rusted. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754547 ↗
• MalfunctionNov 21, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DRILL STOP WAS JAMMED IN THE UNLOCKED POSITION AND WOULD NOT ENGAGE DRILL TO LOCK IT IN. ANOTHER WAS USED WITHOUT DELAY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624219 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING IM TFNA NAILING OF THE HIP, WHILE DRILLING WITH THE 6/9 CANNULATED STEP DRILL, ONE OF THE CUTTING TIPS BROKE OFF IN THE PATIENT'S FEMORAL HEAD. THE REAMER WAS REMOVED, ALL OF THE IMPLANTS AND IRRIGATED UNTIL THE FRAGMENT WAS REMOVED. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED BY ADDITIONAL INTERVENTION. THERE WAS OTHER MEDICAL INTERVENTION THAT IS ADDITIONAL TIME WAS TAKEN TO MAKE SURE REAMER FRAGMENT WAS REMOVED. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047247 ↗
• MalfunctionJan 3, 2025Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING POST OPERATIVE INSPECTIONS FOR THE DRILL STOPS AND BUTTRESS COMPRESSION NUTS RUST WAS DISCOVERED, AND IT WAS NOTED THE THREADS WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066663 ↗
• MalfunctionJan 3, 2025Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING POST OPERATIVE INSPECTIONS FOR THE DRILL STOPS AND BUTTRESS COMPRESSION NUTS RUST WAS DISCOVERED, AND IT WAS NOTED THE THREADS WERE STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066622 ↗
• MalfunctionDec 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER HAS A WEAK DRIVE. THE ISSUE WAS OBSERVED DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925258 ↗
• MalfunctionDec 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CLAMPING SLEEVE HAS NO LONGER HELD. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925234 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE SURGEON IMPLANTED A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) TO TREAT PATIENT'S LEFT INTERTROCHANTERIC FRACTURE. DURING PROCEDURE THE SURGEON HAD A DIFFICULT TIME GETTING THE LATERAL OPENING DRILL AND THE 6/9MM STEP DRILL TO PASS THROUGH THE NAIL. HE PROCEEDED TO IMPLANT THE TFNA LAG SCREW AND ALSO IMPLANT THE DISTAL INTERLOCKING SCREWS. SURGEON DID NOT NOTICE ON INTEROPERATIVE X RAYS THAT THE LAG SCREW WAS ANTERIOR TO THE NAIL. UPON REVIEW OF THE POST OPERATIVE X RAYS SURGEON REALIZED THAT THE LAG SCREW WAS IMPLANTED ANTERIOR TO THE NAIL AND THAT IT DID NOT PASS THROUGH THE NAIL. IT WAS DETERMINED THAT THE NAIL WAS NOT ASSEMBLED TO THE INSERTION HANDLE CORRECTLY WHICH ALLOWED THE ANGLE GUIDE TO ROTATE AND MISS THE NAIL ANTERIOR. REVISION SURGERY WAS PERFORMED ON JULY 13, 2023 WHERE THE NAIL AND LAG SCREW WERE REMOVED WITHOUT ISSUE AND A NEW NAIL AND LAG SCREW WERE IMPLANTED IN THE CORRECT ORIENTATION. THE STATUS OF THE PATIENT AT THIS TIME IS THAT THEY ARE RECOVERING AND THE REVISION NAIL SURGERY WAS SUCCESSFUL. THERE WAS NO DELAY DURING THE REVISION PROCEDURE. THIS REPORT IS FOR ONE (1) UNKNOWN DRILL BIT THIS IS REPORT 1 OF 5 FOR COMPLAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417113 ↗
• InjurySep 6, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022 WHEN PREDRILLING INTO THE PROXIMAL PORTION OF THE FEMUR BEFORE INSERTION OF THE LAG SCREW FOR A TFNA THE TIP OF THE DRILL BIT BROKE OFF. TIP OF THE DRILL BIT WAS LEFT INSIDE THE FEMORAL HEAD. 10MIN SURGICAL DELYED DUE TO THIS EVENT. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DRILL STOP FOR (B)(6) 2022. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15363121 ↗
• InjuryNov 26, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR HER FEMORAL TROCHANTERIC FRACTURE. DURING THE SURGERY, THE GUIDE WIRE SLEEVE BROKE THE EXTERIOR CORTICAL BONE AND CONTACTED WITH THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDEWIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN REAMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) FIX-SLEEVE F/STEPPED REAMER. THIS REPORT IS 6 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10912537 ↗
• MalfunctionApr 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A INTRAMEDULLARY NAILING OF A RIGHT TROCHANTERIC HIP FRACTURE, A SYNTHES 6/9MM DRILL STOP SLIPPED OFF OF THE 85MM INDENTION OF SYNTHES 6/9 STEPPED DRILL BIT. THE SURGEON COMPLETED THE SURGERY SUCCESSFULLY WITHOUT DELAY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439778 ↗