NA 214.552Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982154224), received between Apr 12, 2019 and Dec 9, 2022 — classified as 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT INCORRECT QUANTITIES OR PRODUCT MISSING FROM INSIDE THE MANUFACTURER'S BOX/CASE AND WAS LABELED INCORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 CANNULATED SCREW PARTIALLY THRD/52. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955143 ↗
• MalfunctionApr 12, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN TRAUMA PROCEDURE PERFORMED ON (B)(6) 2019, THE THREAD OF A 52MMX4.5MM CANNULATED SCREW (PARTIALLY THREADED) CAME UNRAVELED AND BROKE OFF INTO THE BONE OF A PATIENT UPON INSERTION OF A GUIDE WIRE. FRAGMENTS WERE GENERATED, AND IT WAS UNKNOWN IF THEY WERE REMOVED EASILY. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE: UNKNOWN GUIDE WIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM CANNULATED SCREW PARTIALLY THREADED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511597 ↗