NA 503004047Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024111547), received between Nov 28, 2018 and Nov 28, 2018 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K123347); 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.

• MalfunctionNov 28, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY, WHILE USING THE COMPRESSION DEVICE, THE TWO DRILL GUIDES USED ALONG WITH IT BUCKLED AT THE POINT WHERE THEY SCREW INTO THE PLATE, THE THREADED SECTION ONE WAS SNAPPED. FOLLOWING THIS THE SURGEONS THEN STRUGGLED TO GET THE LOCKING SCREWS TO SIT FLUSH WITHIN THE PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123347. One submission often covers many models, so check the product and lot details in each record.

• Z-1433-2019 · Apr 8, 2019 · Terminated
  Drill, 2.7x125mm, AO, Item Number 502015217
• Z-1451-2019 · Apr 8, 2019 · Terminated
  Drill, 3.2x145mm, AO, Item Number 502015650