NA 03.033.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886982271068), received between Nov 30, 2018 and Jul 7, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Break” (36 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PIRIFORMIS FOSSA AIMING ARM FOR THE SYNTHES FEMORAL RECON NAIL SYSTEM BROKE WHERE THE CLIPS LOCK INTO THE TROCARS FOR THE HEAD ELEMENTS. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735016 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT AN AIMING ARM WAS DAMAGED ON A CASE. ONE OF THE TWO LOCKING TABS ON THE END OF THE ITEM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068541 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM/INSTRUMENT WAS BROKEN IN ONE OF THE FSN¿S SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544238 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT PLASTIC CLIPS BROKE OFF FOR SELF LOCKING MECHANISM IN DECONTAMINATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085347 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT PLASTIC CLIPS BROKE OFF FOR SELF LOCKING MECHANISM IN DECONTAMINATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085342 ↗
• MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THE DEVICE WAS RECEIVED FOR ANALYSIS: 03.033.002, LOT NO - 508P932. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE. DURING VISUAL EXAMINATION IT WAS DETERMINED THE DEVICE WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 23657675 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHILE INSERTING THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657435 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645597 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645536 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645511 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PIN WAS FALLING OUT AND THE WHITE TAB WON¿T LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583060 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING TRAY INSPECTION IT WAS NOTED THAT THERE WAS A BROKEN TAB ON THE RADIOLUCENT AIMING ARM, FRN PIRIFORMIS FOSSA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629345 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE PIRIFORMIS AIMING ARM IN THE FRNA SET WAS BROKEN WHILE BE HANDLED BY HOSPITAL STAFF. THE GRAY LOCKING LEVER BROKE OFF AT SOME POINT BETWEEN CASES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874696 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AIMING ARM BROKE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576734 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT THE TAB ON AIMING ARM BROKEN. IT DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541792 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS HAVING ISSUES WITH FRN STATIC TRANVERSE HITTING NAIL & MISSING RECON SCREWS. REPLACING AIMING ARM, INSERTION HANDLE, GOLD SLEEVES, MEASURING STICK AND DRIVE CAPS AS WELL. THREADED PORTION IS WORN OUT AND MEASURING STICK IS ILLEGIBLE. THERE WAS NO PATIENT CONSEQUENCES. (B)(4) IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118658 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS HAVING ISSUES WITH FRN STATIC TRANVERSE HITTING NAIL & MISSING RECON SCREWS. REPLACING AIMING ARM, INSERTION HANDLE, GOLD SLEEVES, MEASURING STICK AND DRIVE CAPS AS WELL. THREADED PORTION IS WORN OUT AND MEASURING STICK IS ILLEGIBLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113004 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6)2024, AFTER THE INSTRUMENTS HAD GONE THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE DAMAGED AND WERE NOT ABLE TO BE USED ANYMORE. 1. REPLACEMENT SCREW FOR INSERTION GUIDE THIS ITEM WAS A CONNECTION SCREW FOR THE PROXIMAL HUMERUS DRILL GUIDE ATTACHMENT. THE SCREW WAS LOST AND UNABLE TO BE FOUND. 2. RAD AIMING ARM/FRN PIRIFORMIS FOSSA THIS WAS AN AIMING ARM ATTACHMENT FOR THE FRNA. ONE OF THE PLASTIC FLAPS THAT LOCKS THE DRILL SLEEVE IN PLACE WAS BROKEN. 3. CANNULATED 4.0MM HEXAGONAL SCREWDRIVER THIS ITEM WAS A CALCULATED SCREWDRIVER AND THE TIP OF THE SCREWDRIVER WAS STRIPPED. 4. 4.0MM HEXAGONAL SCREWDRIVER THIS ITEM WAS A SOLID 4 MM HEX SCREWDRIVER. THIS SCREWDRIVER HAD RUST AND WHERE ON THE HANDLE. 5. 2.7/3.5MM DEPTH GAUGE 0 TO 60MM THIS ITEM WAS A DEPTH GAUGE AND THE TIP OF THIS DEATH GAUGE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT WITH THESE ITEMS. IT WAS UNKNOWN HOW THEY WERE DAMAGED OR WHEN THEY WERE DAMAGED. THIS REPORT IS FOR A RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245937 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, A PIECE OF THE DRIVING CAP HAD BROKEN OFF IN THE INSERTION HANDLE. ONE OF THE WHITE TABS THAT LOCKED THE RECON SLEEVES WAS BROKEN, AND THE THREADED END OF THE DRIVING CAP WAS ALSO BROKEN OFF. THESE PIECES NEEDED TO BE REPLACED AS SOON AS POSSIBLE. THIS REPORT IS FOR ONE (1) RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072767 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 2, 2024, THE CONNECTING SCREW ON THE AIMING ARM FOR THE FRN WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827139 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE LOCKING TABS ON THE AIMING ARM, RADIOLUCENT, FOR PIRIFORMIS FOSSA, FEMORAL RECON NAIL HAVE BROKEN AND CAN LONGER LOCK TROCARS IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035839 ↗
• MalfunctionMar 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THERE WASN¿T A DELAY IN SURGERY CAUSED BY THIS EVENT. THE FRNA IMPLANT HAS TWO DIFFERENT PROXIMAL LOCKING OPTIONS. "RECON LOCKING¿ AND THE OTHER ¿STANDARD LOCKING¿. SINCE RECON LOCKING WASN¿T WORKING THE SURGEON WAS ABLE TO PREFORM ¿STANDARD LOCKING¿. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921906 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN INSERTION HANDLE AIMING ARM IS IN NEED OF REPLACEMENT OR REPAIR. THE LOCKING TABS HAVE BROKEN OFF. THIS REPORT INVOLVES ONE (1) RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18319184 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE FEMORAL RECON NAIL PIRIFORMIS FOSSA AIMING ARM AND 11.5/8.5 PROTECTION SLEEVES X2 WERE BENT. THERE WAS NO INJURY TO THE PATIENT OR THE OR STAFF/SURGEON. THE SURGERY WAS DELAYED FOR 30 MINUTES. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT INJURY. THIS REPORT IS FOR ONE (1)RAD AIMING ARM/FRN PIRIFORMIS FOSSA THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076622 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023, THAT, WHILE DRILLING FOR THE RECON SCREW, THE TIP OF THE DRILL BIT BROKE OFF ON THE MEDIAL (FAR) SIDE OF THE NAIL. THE DECISION TO BACK THE NAIL UP AND RE-DRILL WAS MADE. WHILE BACK SLAPPING THE NAIL THE DRIVING CAP BROKE AT THE THREAD SHAFT JUNCTION. THERE WAS A SURGICAL DELAY FOR 10-15 MINS. THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT PRODUCT DETAILS: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN), UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN). THIS REPORT IS FOR ONE (1) RAD AIMING ARM/FRN PIRIFORMIS FOSSA. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367137 ↗