NA 03.010.475Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 10886982068965), received between Dec 21, 2016 and Jan 30, 2026 — classified as 1 injury, 134 malfunctions.

The most frequently reported specific device problem is “Break” (126 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 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A DRIVING CAP BROKE DURING FEMORAL RECON NAILING-ADVANCED (FRNA) SURGERY. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225541 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT THE BLACK TIP OF IMPACTOR BROKE OFF INSIDE THE INSERTION HANDLE AND NOW BOTH ARE UNABLE TO BE USED. THE CASE WAS COMPLETED AND NO PATIENT HARM WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749935 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT THE THREADED PART OF THE INSERTION HANDLE FOR TIBIAL NAILS BROKE. IT WAS FOUND DURING PRODUCT INSPECTION.

  Patient problems: Insufficient Information

  MAUDE report 22756928 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THE SCREW BROKE OFF AT THE END OF THE DRIVING CAP INTRA-OPERATIVELY ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520973 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVE CAPS BROKE OFF WHILE MALLETING THE GT FRNA NAIL. THERE WAS NO PATIENT CONSEQUENCES. THE SURGICAL DELAY AND FRAGMENT GENERATION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969813 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVE CAPS BROKE OFF WHILE MALLETING THE GT FRNA NAIL. THERE WAS NO PATIENT CONSEQUENCES. THE SURGICAL DELAY AND FRAGMENT GENERATION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969783 ↗
• MalfunctionMay 2, 2025Break; Break

  THIS ITEM HAS BEEN BROKEN/DAMAGE. NO PATIENT PROBLEMS WERE REPORTED AND NO PATIENT OR SURGEON DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951925 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT AS THE SURGEON WAS TRYING TO REMOVE THE HAMMER GUIDE FROM THE INSERTION HANDLE, THIS SNAPPED INSIDE THE INSERTION HANDLE AND SO THIS INSERTION HANDLE COULD NO LONGER BE USED AND IT NEEDED CHANGING DURING SURGERY. THERE WAS NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883146 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT WHILE INSERTING A TIBIAL NAIL, THE SURGEON STRUCK THE DRIVING CAP WITH A MALLET, AND IT BROKE IN THE INSERTION HANDLE. ANOTHER SET WAS OPENED AND SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633216 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT THE CUSTOMER SAID THAT THE THREADS OF THE DRIVING CAP INSTRUMENT HAD BROKEN WHEN THE NAIL WAS INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 21631915 ↗
• MalfunctionNov 19, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 20723160 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN INTRAMEDULLARY NAIL PROCEDURE ON (B)(6) 2024. WHEN HAMMERING IN THE NAIL, THE DRIVING CAP SNAPPED OFF STAYING INSIDE THE INSERTION HANDLE. SCRUB STAFF HAD CHECKED IT WAS TIGHT AND SURGEON HAD RECHECKED BEFORE HAMMERING. THE INSERTION HANDLE WAS NOT DAMAGED AS THE PART THAT WAS STUCK WAS ABLE TO BE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE. THIS REPORT IS FOR A DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755150 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING NAIL INSERTION, WHEN THE SURGEON STRUCK THE DRIVING CAP THE THREADED PORTION BROKE OFF AND BECAME LODGED IN THE INSERTION HANDLE. THE NAIL WAS ALREADY FULLY INSERTED SO THE CASE WAS ABLE TO PROCEED. THE BROKEN FRAGMENT FROM THE INSERTION HANDLE WAS ABLE TO BE REMOVED WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION. THIS REPORT IS FOR A DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18597065 ↗
• MalfunctionOct 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DRIVING CAP/CONNECTOR BROKE OFF INSIDE THE SUPRAPATELLAR INSERTION HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961239 ↗
• MalfunctionSep 26, 2023Break; Break

  THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821807 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AIMING ARM AND DRIVING CAP WERE DROPPED WHILE CONNECTED, THREADED PORTION OF DRIVING CAP SNAPPED OFF INSIDE OF THE AIMING ARM. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641443 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023, DRIVE CAP FOR SUPRA PATELLA TIBIA SET WAS GIVEN. STERILE PROCESSING DEPARTMENT (SPD) NOTICED THAT DRIVE CAP WAS BROKEN OFF IN INSERTION HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE DRIVING CAP FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596806 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE WHEN THEY WERE INSERTING A FRNA NAIL WHEN THE IMPACTOR BROKE AFTER 2 MALLET BLOWS. THE IMPACTOR BROKE RIGHT WHERE IT SCREWS INTO THE INSERTION HANDLE. ANOTHER PEEL PACK INSTRUMENTS WERE OPENED TO REPLACE BROKEN IMPACTOR. WITH THE PEEL PACKED IMPACTOR AND INSERTION HANDLE THE REATTACHMENT OF NAIL WAS DONE. SURGERY WAS COMPLETED WITH A DELAY OF 10 MINUTES. CONCOMITANT DEVICE REPORTED: UNK - NAILS (PART# UNKNOWN, LOT# UNKNOWN. QUANTITY: 1). THIS REPORT IS FOR DRIVING CAP FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541016 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO PRODUCTS BROKE DURING SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY/ THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRIVING CAP THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965269 ↗
• MalfunctionMay 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP/THREADED IS IMPACTED AND NEEDS TO REPLACED. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DRIVING CAP WAS BROKEN FROM THE TIP, THE BROKEN FRAGMENT WAS RETURNED LODGED INTO THE MATING DEVICE (PERCUTANEOUS INSERTION HANDLE FRN). THIS REPORT IS FOR ONE (1) DRIVING CAP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16880957 ↗
• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763394 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP THREAD BROKE OFF. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689273 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON WAS INSERTING THE NAIL WITH THE INSERTION HANDLE BY HITTING THE DRIVE CAP WHEN THE THREADED PORTION OF THE DRIVE CAP BROKE OFF INTO THE INSERTION HANDLE. THERE WAS NO NEGATIVE CONSEQUENCE TO THE PATIENT EXCEPT A SLIGHTLY DELAY IN SURGERY FOR 5 MINUTES. OPENED ANOTHER TRAY TO OBTAIN NEW INSTRUMENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. UNK NAILS PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN. THIS REPORT IS FOR ONE (1) DRIVING CAP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683835 ↗
• MalfunctionApr 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, AN EVENT OCCURRED WHILE EXTRACTING THE TFNA NAIL, THE MALLET BECAME COLD WELDED TO THE DRIVE CAP. UNABLE TO TAKE OFF MALLET AND DRIVE CAP. A NEW SET WAS OPENED TO FINISH PROCEDURE. THERE WAS A SURGICAL DELAY OF 10 MINUTES. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678231 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE INSERTING A FEMORAL RECON NAIL, THE SURGEON WAS HITTING THE DRIVE CAP WITH A MALLET WHEN THE DRIVE CAP BROKE IN HALF. ANOTHER DRIVE CAP PEEL PACKED AND WERE ABLE TO UNSCREW THE BROKEN ONE AND PUT ON THE NEW ONE AND CONTINUE THE CASE WITH NO ISSUES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND WERE REMOVED BY ADDITIONAL INTERVENTION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657862 ↗