NA 02.226.740Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982060204), received between Jan 6, 2021 and Jan 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE (5) NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: T15 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN (PART # 03.333.304, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM HEADLESS COMPRESSION SCREW/LONG THREAD/40MM. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127162 ↗