NA 292.619Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20886982180688), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K012945); 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.

• MalfunctionMar 28, 2018Bent; Bent

  IT WAS REPORTED THAT WHEN USING 2.4MM CANNULATED SCREW SET AND DRILLING OVER A 0.8MM GUIDE WIRE AND TAKING DRILL BIT OUT AFTER DRILLING, IT WAS NOTICED THAT THE TIP OF THE DRILL BIT HAD BROKEN OFF. FRAGMENTS OF THE DRILL BIT WERE LEFT IN PATIENT. ALSO DURING THIS FOOT PROCEDURE, ONE OF THE 0.8MM GUIDE WIRES WAS BENT DURING INSERTION OF A SCREW. THE BENT GUIDE WIRE WAS TAKEN OUT AND REPLACED WITH A NEW ONE. THERE WAS 5-7 MINUTES DELAY IN THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 2.4MM CANNULATED SCREW (PART 211.820, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 0.8MM GUIDE WIRE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012945. One submission often covers many models, so check the product and lot details in each record.

• Z-0890-2013 · Feb 12, 2013 · Terminated
  Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antiprur