NA 03.045.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 10886982292551), received between Jul 26, 2021 and Sep 30, 2026 — classified as 7 injuries, 265 malfunctions.

The most frequently reported specific device problem is “Break” (224 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 272 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951042 ↗
• MalfunctionSep 28, 2026Break; Entrapment of Device

  It was reported that during the procedure, the tip of the short quick-anchor retaining pin fractured occurred. The fractured fragment was anchored in the head of the 5 L40 nail locking screw. Faced with this situation, the specialist requested the supply of a new screw, indicating that this screw should not be charged as part of the expenses of the procedure. There was no patient harm or surgical delay.

  Patient problems: Foreign Body In Patient

  MAUDE report 50913944 ↗
• MalfunctionSep 25, 2026Break

  It was reported during the procedure, the tip of the Short Quick Anchor Retention Pin fractured. The fractured fragment remained lodged in the head of the Locking Screw for the Nail. Another Screw was used to complete the procedure successfully. It was also noted that a Drill Bit showed significant wear and loss of sharpness.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898837 ↗
• MalfunctionSep 25, 2026Break

  It was reported that the threaded tip of Retention Pin for Screwdriver, short broke off while inserting a screw intraoperatively. The account sees this as a patient safety issue as the broken part of the retention pin is too tiny that it is not easily noticeable. There was no surgical delay.

  Patient problems: Insufficient Information

  MAUDE report 50896840 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858971 ↗
• MalfunctionSep 15, 2026Break

  It was reported the threads of retention pins have broken off. Event was found post-operatively. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770631 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696333 ↗
• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356170 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223928 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED ON 6TH MAY, 2026 THAT SPD NOTIFIED THE REPORTER OF 2 INSTRUMENTS THAT WERE BROKEN AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25293281 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED ON 6TH MAY, 2026 THAT SPD NOTIFIED THE REPORTER OF 2 INSTRUMENTS THAT WERE BROKEN AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25293272 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED ON 6TH MAY, 2026 THAT SPD NOTIFIED THE REPORTER OF 2 INSTRUMENTS THAT WERE BROKEN AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292695 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THAT SPD NOTIFIED THE REPORTER OF 2 INSTRUMENTS THAT WERE BROKEN AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292647 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED DURING AN UNKNOWN TRAUMA SURGERY ON (B)(6) 2026, AN INTER-MEDULLARY NAIL OF THE FEMUR, THE RETENTION PIN FOR THE XL 25 RETENTION SCREWDRIVER SNAPPED WITHIN THE XL25 SCREW. THERE WAS NO PATIENT HARM OR SURGERY DELAY AS A RESULT OF THE PRODUCT. THE PATIENT WAS UNAFFECTED AS A RESULT OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254866 ↗
• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN WON'T RETAIN TO SCREWS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148925 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RETENTION PIN BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094906 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE STRIKING CAP AND THE RETENTION PIN BROKE WHILE INSERTING NAIL AND SCREWS. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069753 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER BROKE OFF DURING CASE. NO IMPACT TO PATIENT. SCREW DRIVER IS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717001 ↗
• MalfunctionMar 30, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED TIP OF THE RETENTION PIN INTENDED FOR A 12 MM SHORT HEXAGONAL RAPID-ANCHORING SCREWDRIVER SNAPPED OFF, LEAVING IT LODGED INSIDE THE SCREW. THE SPECIALIST RESOLVED THE ISSUE BY USING ANOTHER SCREWDRIVER, ALLOWING THE SURGERY TO FINISH SUCCESSFULLY WITHOUT PATIENT IMPACT OR ALTERATION IN SURGICAL TIMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24716540 ↗
• MalfunctionMar 26, 2026Break

  DURING THE PROCEDURE, WHILE TIGHTENING THE SCREW, THE TIP OF THE RETAINING PIN FOR THE 12MM HEXAGONAL QUICK-RELEASE SCREWDRIVER BROKE. THIS WAS RESOLVED USING ANOTHER SCREWDRIVER THAT WAS ALSO INCLUDED IN THE KIT, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY, WITHOUT DISCOMFORT FOR THE SPECIALIST, WITHOUT AFFECTING THE PATIENT, AND WITHOUT ALTERING THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703091 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  THE RETENTION PIN WON¿T STAY IN THE DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 24558747 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25, T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN, 2.7MM CANN DRILL BIT QC/145MM, SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE, MONOBLOC FLEXIBLE REAMER 14 - STD - DD, MONOBLOC FLEX REAMER 14.5 - LONG - DD, DRIVE SHAFT FOR RIA 2 520MM, T25 SDDRIVE SCREWDRIVER SHAFT 241MM, AND TORQUE LIMITING ATTACHMENT 4NM FOR AO REAMING COUPLER WERE REPORTED AS DAMAGED DURING POST-OPERATIVE INSPECTION. THE FAILURES INCLUDED BROKEN TIPS, STRIPPED FEATURES, RUST INSIDE CANNULAS, AND NON-FUNCTIONING TORQUE LIMITER. THERE WAS NO PATIENT INVOLVEMENT OR HARM, AND NO PROCEDURE WAS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533287 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT THE TIP OF RETENTION PIN IS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490284 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT THE THREADED PORTION OF THE SCREWDRIVER WAS BROKEN OFF INTRAOPERATIVELY. THERE WAS A 5 MINUTES OF DELAY IN SURGERY. THE SCREW WAS THEN INSERTED BY USING A DIFFERENT SCREWDRIVER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446974 ↗
• MalfunctionFeb 19, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE RETENTION PIN W/QUICK-COUPL HEX 12 SHORT WAS BROKEN INTO TWO OR MORE PIECES DURING A SURGICAL PROCEDURE. THE THREADED PART OF THE RETENTION PIN, WHICH IS INSERTED INSIDE THE SCREWDRIVER TO KEEP THE SCREW IN A FIXED POSITION, FRACTURED WHILE THE PROXIMAL FREEHAND BLOCK OF THE NAIL WAS BEING PERFORMED. THE FRAGMENT OF THE PIN REMAINED EMBEDDED WITHIN THE SCREW AND WAS NOT REMOVED AT THE TIME OF WOUND CLOSURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT, AND THE SCREW WAS PROPERLY BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389043 ↗