NA 03.010.497Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982069146), received between Sep 27, 2018 and Dec 1, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING DEVICE WAS BROKEN. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681507 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A DAMAGED ITEM WAS RECEIVED AT CUSTOMER SIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266686 ↗
• MalfunctionJan 15, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A FEMORAL NAILING PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE "CLIP" FELL OFF OF THE FRNA AIMING ARM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161797 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT ON MAR 1, 2024, THE STAFF FOUND THE DEVICE WHILE INVENTORYING A TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RAD AIMING ARMS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059371 ↗
• MalfunctionMar 6, 2024Device Slipped; Detachment of Device or Device Component; Device-Device Incompatibility; Device Slipped; Detachment of Device or Device Component; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 19, 2024 DURING INSERTION OF FEMORAL RECON NAILING -ADVANCED (FRNA) NAIL, THE FRICTION LOCKING MECHANISM FOR PROTECTION SLEEVE 11.5/8.5 FELL OFF ON THE FLOOR. AFTER SURGERY, THE JIG WAS INSPECTED AND ALL 4 BOLTS THAT IS HOLDING THE TWO FRICTION LOCKING MECHANISM WERE LOOSE. IF PUSHED IN, IT SLIDES OUT AGAIN IF THE JIG IS FACING DOWN. THERE WAS NO SURGICAL DELAY, OTHER THAN THAT UNSTERILE NURSE HAD TO PICK UP THE ¿PUSH TO LOCK¿ ITEMS FROM THE FLOOR THAT FELL OFF. THESE ARE USED TO LOCK THE SLEEVE TO RECON LOCKING MODE WHICH WAS NOT NEEDED OR PLANNED FOR THIS PATIENT. PATIENT OUTCOME IS REPORTED AS PLANNED. THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18851138 ↗
• MalfunctionFeb 27, 2024Device Slipped; Detachment of Device or Device Component; Device-Device Incompatibility; Device Slipped; Detachment of Device or Device Component; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 19, 2024 DURING INSERTION OF FEMORAL RECON NAILING -ADVANCED (FRNA) NAIL, THE FRICTION LOCKING MECHANISM FOR PROTECTION SLEEVE 11.5/8.5 FELL OFF ON THE FLOOR. AFTER SURGERY, THE JIG WAS INSPECTED AND ALL 4 BOLTS THAT IS HOLDING THE TWO FRICTION LOCKING MECHANISM WERE LOOSE. IF PUSHED IN, IT SLIDES OUT AGAIN IF THE JIG IS FACING DOWN. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18792314 ↗
• MalfunctionMay 26, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE AIMING ARM REQUIRED REPLACEMENT AT THE JUNCTION WHERE THE CLIPS LOCK. IT WAS WORN DOWN AND DID NOT RETAIN THE CLIPS. THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888750 ↗
• MalfunctionMay 4, 2021Break; Break

  UPDATED EVENT DESCRIPTION: THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769153 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RADIOLUCENT AIMING ARM WAS BROKEN. ISSUE WAS DISCOVERED UPON ROUTINE INSPECTION OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224826 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INSERTING A FEMORAL RECON NAIL (FRN) THE DRIVING CAP/THREADED STRIKE PLATE WAS BEING USED TO INSERT THE NAIL AND AS THE SURGEON WAS HITTING IT WITH THE HAMMER, THE STRIKE PLATE BECAME LOOSE AND WAS STRUCK. THE TIP OF IT BROKE OFF INSIDE THE AIMING ARM. THE RADIOLUCENT INSERTION HANDLE FRN THIS PIECE AS THE TIP OF THE STRIKE PLATE STUCK INSIDE THE AIMING ARM. THE RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER ITEM WAS BEING USED TO INSERT THE RECON SCREWS INTO THE HEAD AND NECK OF THE FEMUR AND WAS STRUCK BY THE HAMMER AND THE PLASTIC LOCKING DEVICE WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACK-UP INSTRUMENTS. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN NAILS FEMORAL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN IMPACTION INSTRUMENTS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), RADIOLUCENT INSERTION HANDLE FRN (PART# 03.033.00,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224415 ↗
• MalfunctionNov 7, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FEMORAL RECON NAIL INSTRUMENT SET WAS RECEIVED WITH A BROKEN RADIOLUCENT AIMING ARM. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. DURING MANUFACTURER'S PRELIMINARY ANALYSIS ON (B)(6) 2019 IT WAS IDENTIFIED THAT CAM LOCK WHICH IS A SUB-COMPONENT OF RADIOLUCENT AIMING ARM IS BROKEN. CONCOMITANT DEVICE: UNKNOWN FEMORAL RECON NAIL SET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9291995 ↗
• MalfunctionOct 23, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A RADIOLUCENT AIMING ARM WAS RECEIVED WITH A BROKEN TROCAR LOCKING CLIP AND WAS NOT AVAILABLE TO BE USED IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR ONE (1) CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9225928 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED ON JUNE 11, 2019, UPON OPENING THE INSTRUMENTS TO BUILD THE SETS, THE SALES CONSULTANT FOUND THE RADIOLUCENT AIMING ARM/FEMORAL RECON NAIL (FRN) PIRIFORMIS FOSSA TO HAVE A BROKEN TAB ON THE LOCKING MECHANISM FOR THE RECON GUIDE TUBE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8777562 ↗
• MalfunctionApr 3, 2019Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION ON (B)(6) 2019, IT WAS OBSERVED THAT THE CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES: RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA (PART: 03.033.002, LOT: L924561, QUANTITY: 1), CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS (PART: 03.010.497, LOT: T167964, QUANTITY: 1). THIS REPORT IS FOR A CAM LOCK LEVER FOR RADIOLUCENT AIMING ARMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8480005 ↗
• MalfunctionMar 25, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A CAM LOCK LEVER FOR RADIOLUCENT AIMING ARM WAS ACCIDENTALLY BROKEN BY A TOTE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA(PART # 03.033.002, LOT# L963555, QUANTITY# 1).

  Patient problems: No Patient Involvement

  MAUDE report 8450094 ↗
• MalfunctionSep 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE CAM LOCK LEVER FOR RADIOLUCENT AIMING ARM WAS BROKEN OFF UPON INSPECTION WHEN THE FEMORAL RECON NAIL SET WAS OPENED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: RADIOLUCENT AIMING ARM (PART# 03.033.003, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7915054 ↗