NA 352.312Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034770772), received between Mar 23, 2020 and Mar 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMar 23, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE HOLDING SLEEVE TONGS WAS BENT 45 DEGREES WHILE SCREWING IN THE SCREW. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866315 ↗