NA 202.636Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982144447), received between Jan 11, 2019 and Jan 11, 2019 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K951304, K962823); they may or may not involve this specific model.

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

• MalfunctionJan 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INCOMING RECEIVING INSPECTION AT FIELD STOCKING LOCATION FACILITY THE CANNULATED SCREWS SHORT THREAD WAS FOUND TO BE BENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0MM CANNULATED SCREW SHORT THREAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8241923 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951304, K962823. One submission often covers many models, so check the product and lot details in each record.

• Z-2265-2014 · Jun 30, 2014 · Terminated
  Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set