NA SD03.033.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982310699), received between Sep 7, 2022 and May 13, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPACTOR BROKE OFF IN GUIDE DURING SURGERY. PATIENT WAS UNHARMED. THE SURGERY WAS DELAYED UNTIL A SECOND HANDLE WAS FOUND. ADDITIONAL IMPACTOR WAS NOT AVAILABLE. NO ITEMS WERE LEFT IN OR BROKE OFF INTO THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009950 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT ON 05-FEBRUARY-2024 THE STRIKING CAP THREADS BROKE OFF IN THE PERCUTANEOUS FRNA HANDLE IN QUESTION. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE PATIENT IMPACT. THE INSERTION HANDLE IS NOT ABLE TO BE USED IN SUBSEQUENT SURGERIES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731132 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE THE INSERTION HANDLE AND DRIVING CAP BROKE. THIS WAS DISCOVERED AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384596 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT ON 30-JUNE-2023 DURING AN UNKNOWN PROCEDURE, THE IMPACTOR BROKE WHILE INSERTING THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371125 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LIST OF BROKEN ITEMS COLLECTED FROM THE SPD OF ACCOUNTS IN T241. ALL ITEMS WERE DISCOVERED BROKEN AT POST-OP AND DID NOT EFFECT SURGICAL CAPABILITIES. REPLACEMENT NEEDED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 12 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079494 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LIST OF BROKEN ITEMS COLLECTED FROM THE SPD OF ACCOUNTS IN T241. ALL ITEMS WERE DISCOVERED BROKEN AT POST-OP AND DID NOT EFFECT SURGICAL CAPABILITIES. REPLACEMENT NEEDED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 11 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079486 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT WHILE INSERTING A FEMORAL RECON NAIL, IMPACTION CAPS IN THE HANDLE WERE DAMAGED. IT HAPPENED TWO TIMES INSERTING A NAIL, WITH TWO OF EACH BEING DAMAGED. THIS REPORT INVOLVES ONE PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860616 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT WHILE INSERTING A FEMORAL RECON NAIL, IMPACTION CAPS IN THE HANDLE WERE DAMAGED. IT HAPPENED TWO TIMES INSERTING A NAIL, WITH TWO OF EACH BEING DAMAGED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860614 ↗
• MalfunctionDec 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS INSERTING A FEMORAL RECON NAIL WHEN THE STRIKING CAP BROKE OFF INSIDE THE JIG WHERE IT ATTACHES. THERE WAS NO DELAY IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060467 ↗
• MalfunctionSep 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DRIVING CAP BROKE OFF INSIDE OF THE INSERTION HANDLE WHILE INSERTING THE NAIL INTO THE FEMUR. THE BROKEN PIECE WAS UNABLE TO BE REMOVED FROM THE INSERTION HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A PERCUTANEOUS INSERTION HANDLE FRN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374489 ↗