NA 03.168.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982274441), received between Dec 13, 2018 and Sep 4, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (23 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Material Deformation

  It was reported on (b)(6) 2026, that upon retrieving Femoral Neck System set from wash, it was found that the drill sleeve was damaged. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611072 ↗
• MalfunctionSep 19, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE PROTECTION SLEEVE BENT DURING USE. IT WAS BROKEN DURING USE IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094456 ↗
• MalfunctionJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE TRILEAP MPJ PLATE WAS USED AND SCREW DID NOT LOCK IN, UNSURE IF IT WAS BECAUSE USED A CONICAL EXTRACTOR TO REMOVE SCREW. 2.0 PLATE ALSO DID NOT LOCK IN. RUST ON GRAPHIC CASES AND INSTRUMENTS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574756 ↗
• MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE TRILEAP MPJ PLATE WAS USED AND SCREW DID NOT LOCK IN, UNSURE IF IT WAS BECAUSE USED A CONICAL EXTRACTOR TO REMOVE SCREW. 2.0 PLATE ALSO DID NOT LOCK IN. RUST ON GRAPHIC CASES AND INSTRUMENTS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567239 ↗
• MalfunctionFeb 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE END OF FNS 4.3 DRILL GUIDE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426982 ↗
• MalfunctionFeb 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE PROTECTION SLEEVE APPEARED TO BE COMPRESSED AND DRILL BIT COULDN'T GO THROUGH CORRECTLY. THE DEVICE WAS SWAPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307535 ↗
• MalfunctionJan 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SLEEVE WAS CHEWED UP. THERE WAS NO PATIENT OR OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277107 ↗
• MalfunctionJan 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TROCAR WAS BENT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149666 ↗
• MalfunctionJan 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE DRILL SLEEVE BENT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072036 ↗
• MalfunctionOct 28, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS DAMAGED DURING CLEANING OR SURGERY AT SOME POINT. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545085 ↗
• MalfunctionJul 31, 2024Material Deformation; Material Deformation

  IT WAS REPORTED ON JUL 9, 2024 UPON INVENTORYING SETS SLEEVE END WAS A BIT DENTED AROUND THE EDGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR FNS INSRT INSTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878912 ↗
• MalfunctionJul 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DENTED PROTECTION SLEEVE FOR FEMORAL NECK SYSTEM IS DENTED ON THE BOTTOM. ALSO, A CHIPPED CRUCIFORM SHAFT FOR SCREW REMOVAL SET AND A BENT PIN WRENCH FROM THE SCREW REMOVAL SET. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR FNS INSRT INSTS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800496 ↗
• MalfunctionFeb 15, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 BEFORE A PROCEDURE, THE FNS PROTECTION SLEEVE IN QUESTION WAS FOUND TO BE BENT. THE DRILL WOULD NOT PASS THROUGH THE SLEEVE AS INTENDED. THERE WAS NO PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710614 ↗
• MalfunctionJan 16, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING STERILIZATION INSPECTION ON AN UNKNOWN DATE, THE END OF THE FEMORAL NAIL SYSTEM (FNS) TROCAR WAS BENT AND THE DRILL WOULD NOT FIT THROUGH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519723 ↗
• MalfunctionNov 8, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE FEMORAL NECK SCREW LOAN SET HAD A DAMAGED PROTECTION SLEEVE FOR THE DISTAL LOCKING SCREW JIG . NO IMPACT TO PATIENT OR SURGEON OCCURRED, AS I HAD A SPARE STERILE CONSIGNED INSTRUMENT SET AT THE HOSPITAL. IT WAS JUST FLAGGED AND TAGGED BY THE LOAN TEAM AT THE HOSPITAL. THIS ITEM NEEDS TO BE REPLACED IN THE LOAN SET. THERE WERE NO PATIENT CONSEQUENCES OR INVOLVEMENT. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE F/INSERTION INSTR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093783 ↗
• MalfunctionAug 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, PROTECTION SLEEVE WAS ACCIDENTALLY JAMMED INTO HOLE NUMBER 2 INSTEAD OF HOLE NUMBER 1 WITH A MALLET BY THE SURGEON AND IT SMASHED THE END OF THE SLEEVE RENDERING IT UNUSABLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568667 ↗
• MalfunctionMar 29, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PROTECTION SLEEVE FOR THE FNS SYSTEM WAS DENTED AND DAMAGED. THERE WAS NO PATIENT CONSEQUENCES/OUTCOME. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR FNS INSRT INSTS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639297 ↗
• MalfunctionMar 23, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A COUPLE OF FNS ITEMS WERE FOUND DAMAGED AFTER DECONNING. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE PROTECTION SLEEVE FOR FNS INSRT INSTS HAD THE DISTAL TIP HEAVILY DEFORMED. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601202 ↗
• MalfunctionFeb 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 1/27/2023. THE TIP OF DRILL SLEEVE WAS BENT, HOWEVER, THE CASE PROCEEDED AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE FOR FNS INSRT INSTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397998 ↗
• MalfunctionNov 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON INSPECTION IN SPD ON (B)(6) 2022, IT WAS NOTED THAT THE TIP WAS MARRED AND BENT. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788679 ↗
• MalfunctionMay 11, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PARTS OF PROTECTION SLEEVE TIP WAS BROKE/MISSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE PROTECTION SLEEVE FOR FNS INSTR INST'S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360248 ↗
• MalfunctionMar 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IMPLANTATION OF AN FNS. DRILLING THE LOCKING HOLE FOR INSERTING THE 5.0 LOCKING SCREW. THE DRILL GOT STUCK IN THE PROTECTION SLEEVE, FOR FEMORAL NECK SYSTEM INSERTION INSTRUMENTS. THE DR COULD NOT MOVE THE DRILL IN ANY WAY. THE FNS WAS TAKEN OUT OF THE PATIENT AND AN DHS WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13907974 ↗
• MalfunctionFeb 23, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING AN FNS PROCEDURE AT HOKE HOSPITAL. GOT BOLT AND PLATE CONSTRUCT IN PATIENT AND THEN WENT TO INSERT PROTECTION SLEEVE PRIOR TO FILLING FOR LOCKING SLEEVE. THE SURGEON COULD NOT GET DRILL THROUGH SLEEVE, EVEN WHEN SLEEVE IS FULLY LOCKED IN TO INSTRUMENTATION. ONCE HE BROKE CORTEX, HE TRIED TO GO AHEAD AND INSERT 5.0 LOCKING SCREW. SCREW HEAD WOULD NOT ADVANCE PAST END OF SLEEVE. WE TOOK SLEEVE OFF TO EXAMINE AND FOUND THAT THE END OF SLEEVE CLOSEST TO BONE HAD WARPED METAL AT END. IT WAS BENT AND NOT PERFECTLY CIRCULAR THEREFORE CAUSING THE SCREW HEAD TO NOT GET PAST IT AT THE JUNCTION. HAD DELAY OF 20-25 MINUTES IN OPERATION DUE TO THE PRODUCT ISSUE. WE WERE ABLE TO FINISH OPERATION WITH NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE PROTECTION SLEEVE FOR FNS INSERT INSTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586745 ↗
• MalfunctionFeb 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE ON (B)(6), 2022, IT WAS DISCOVERED THAT THE TIP OF THE PROTECTION SLEEVE WAS DAMAGED. THE PROCEDURE HAS BEEN COMPLETED WITH NO DELAY AND THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BENT. THIS REPORT IS FOR A PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545972 ↗
• MalfunctionAug 31, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DAMAGED TROCHAR AND FNS FELL ON THE FLOOR DURING AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393521 ↗