NA 311.32Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982187345), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 malfunction.

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

• MalfunctionJul 26, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR OBLIQUE FRACTURE OF THE TIBIAL TUBERCLE WITH TAP FOR CORTEX SCREW 3.5MM. COMPRESSION FIXATION BETWEEN BONE FRAGMENTS WAS PERFORMED USING THE LAG SCREW METHOD WITH CORTEX SCREW 3.5MM. THE SURGEON PERFORMED THE TAPPING AFTER THE DRILL WAS COMPLETE. IN DOING SO, HE KEPT PUSHING AND TURNING THE HANDLE WITH THE TAP DISPLACED FROM THE HOLE ON THE CONTRALATERAL SIDE. AS A RESULT, EXCESSIVE FORCE WAS APPLIED TO THE TAP AND THE TIP OF THE TAP WAS DAMAGED. ABOUT 1/3 OF THE TIP OF THE TAP WAS REMAINED IN THE PATIENT'S MEDULLARY CAVITY. THE SURGEON DETERMINED THAT EXTRACTION WOULD BE DIFFICULT AND CONTINUED WITH PLATE FIXATION. THE SURGEON COMPLETED THE TIBIAL PLATE FIXATION. THE SURGEON ALSO INFORMED THE PATIENT ABOUT WHAT REMAINED IN THE BODY POSTOPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS LISTED AS STABLE CONCOMITANT DEVICE REPORTED: UNK - PLATES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNK - SCREWS: 3.5 MM CORTEX (PART# UNKNOWN, LOT# UNKNOWN). THIS REPORT IS FOR ONE TAP FOR 3.5MM CORTEX SCREWS GOLD/110MM FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17401174 ↗