NA 219447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705006533), received between Sep 12, 2019 and Sep 12, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 12, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT HIS 5X12 AND 6X12MM MODULAR DRIVER AND 7X15 AND 8X15MM MODULAR DRIVER WERE BENT BY THE TIPS WERE BENT AND HIS TENDON SIZER 4-9MM HAD FADED LASER LINES DURING A BICEP PROCEDURE. THE CASE WAS COMPLETED WITH OTHER LIKE DEVICES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICES WERE DISCARDED BY THE CUSTOMER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9010487 ↗