NA 03.045.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982292599), received between Sep 20, 2022 and Feb 5, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED INTRA-OPERATIVELY, A DRILL BIT BROKE. WHILE TRYING TO RETRIEVE THE BROKEN DRILL BIT, THE HOLLOW REAMER BROKE. ANOTHER DRILL BIT WAS USED TO REDRILL SUCCESSFULLY. A 6.5MM RECON SCREW GOT STUCK AFTER TAPPING MULTIPLE TIMES. WHILE TRYING TO REMOVE THE STUCK SCREW, A SCREWDRIVER WAS DAMAGED. AN EXTRACTION SCREW ALSO STRIPPED DURING THE SURGERY. THE SURGEON WAS NOT ABLE TO IMPLANT THE RECON SCREW SO CHANGED TO THE SURGICAL PLAN TO ACCOMMODATE TRANSVERSE LOCKING ONLY. THE PROCEDURE WAS COMPLETED WITH A ONE-HUNDRED TWENTY (120) MINUTE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24272628 ↗
• MalfunctionNov 19, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE THREADS WERE CHIPPED/DENTED. THERE WAS NO PATIENT INVOLVED AND NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593896 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON (B)(6) 2023, A SCREWDRIVER XL25 AND RETENTION PIN XL40 WERE STUCK TOGETHER. THIS REPORT IS FOR A RETENTION PIN FOR SCREWDRIVER XL40. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694325 ↗
• MalfunctionSep 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SALES CONSULTANT HAS A RETENTION PIN IS STUCK INSIDE A SCREWDRIVER. THERE WAS NO PATIENT INVOLVEMENT . CONCOMITANT PRODUCT: SCREW DRIVER/CANNULATED/XL25 (PART #03.045.001, QUANTITY #1). THIS REPORT IS FOR ONE (1) RETENTION PIN FOR SCREWDRIVER XL40. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459167 ↗