NA 219973Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705021796), received between Sep 26, 2019 and Oct 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT BEFORE AN UNKNOWN PROCEDURE THE DISTAL TIP OF THE MODULAR TENODESIS DRIVER 23 MM WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674393 ↗
• MalfunctionSep 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY AN EMPLOYEE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE, AT THE START OF THE CASE, THE 23 MM MODULAR TENODESIS DRIVER TIP OF THE SHAFT WAS BENT. THE CASE WAS COMPLETED BY USING A 30 MM DRIVER TO SCREW IN THE MILGRO ANCHOR WITH NO PATIENT HARM OR DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125336 ↗