NA 03.033.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982271082), received between Mar 6, 2020 and Jun 25, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Crack

  IT WAS REPORTED THAT BEFORE USING THE SET THE NURSE IDENTIFIED THAT THE DRILL BIT HAD A CRACK IN THE SHAFT. THEY UTILIZED AN ALTERNATIVE REAMER INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623577 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE ITEM CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402105 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 14MM CANNULATED DRILL BIT FLEXIBLE. THIS IS REPORT 8 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694245 ↗
• MalfunctionOct 17, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2022, WHILE PERFORMING A FRN NAIL, THE SURGEON SAID THAT THE 14MM OPENING DRILL BIT BECAME DULL. ANOTHER DRILL HAD TO BE SELECTED AND THE SURGERY PROCEEDED. WHILE MEASURING FOR THE RECON SCREWS INT THE NAIL, THE 8.5/3.2 WIRE GUIDE BECAME STUCK. IT WAS DIFFICULT TO REMOVE AND EVENTUALLY WAS SUCCESSFULLY REMOVED. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 5 MINUTES. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT FLEXIBLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614766 ↗
• MalfunctionMay 24, 2022Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS PERFORMING A PIRIFORMIS FEMORAL RECON NAIL. AFTER FINISHING THE OPENING DRILL BIT USING CANNULATED DRILL BIT FLEXIBLE WAS BROKEN NEAR THE PROXIMAL END OF THE DRILL BIT. LATER IN THE CASE, THE RETENTION PIN SCREWDRIVER WAS USED AND IT WAS NOTICED THAT THE TIP OF THE RETENTION WAS MISSING. IT DID NOT BREAK IN THIS CASE AND IT WAS UNSURE WHEN IT WAS BROKEN. THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO HARM CAUSED TO PATIENT AND NO BROKEN FRAGMENTS IN PATIENT. THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT FLEXIBLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488534 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DRILL TIP BROKE. IT WAS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 14MM CANNULATED DRILL BIT FLEXIBLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562000 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE DRILL BIT BROKE. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT FLEXIBLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300667 ↗
• MalfunctionJul 8, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTER FOUND SIX (6) DAMAGED ITEMS IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 14MM CANNULATED DRILL BIT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10247751 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT DURING A FEMORAL NAIL SURGERY WITH FEMORAL RECON NAIL SYSTEM (FRN) ON FEBRUARY 11, THE IMPACTOR BROKE OFF OF THE INSERTION HANDLE AND A DRILL BIT WAS BROKEN OFF IN THE SAME EXACT SURGERY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. SURGICAL DELAY OF TWENTY (20) MINUTES WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: RADIOLUCENT INSERTION HANDLE FEMORAL RECON NAIL (PART#03.033.001, LOT#L551415, QUANTITY 1); DRIVING CAP/THREADED (PART # 03.010.523, LOT # L504146, QUANTITY 1). THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT FLEXIBLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9800418 ↗