NA 03.900.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982080677), received between Jan 23, 2018 and Oct 16, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionOct 16, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CRUCIFORM END OF THE SCREWDRIVER SHAFT BROKE. THE ISSUE WAS FOUND OUT AT A DECONTAMINATION UNIT. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4MM CRUCIFORM SCRWDRVR SHAFT 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7970273 ↗
• InjuryJan 23, 2018Break; Break

  IT WAS REPORTED THAT A CRUCIFORM SCREWDRIVER TIP BROKE INTRAOPERATIVELY (B)(6) 2017 DURING A PLANNED HARDWARE REMOVAL OF A 2.4 MM SCREW. THE TIP FRAGMENT WAS UNABLE TO BE RETRIEVED AND REMAINS IMPLANTED. THERE WAS NO REPORTED DELAY IN THE SURGERY, AND NO REPORTED HARM TO THE PATIENT. PATIENT OUTCOME WAS GOOD. THE PROCEDURE WAS A PLANNED HARDWARE REMOVAL FROM THE LEFT TALUS. THERE WAS NO REPORTED PRODUCT PROBLEM, AND THE PATIENT WAS HEALED. REPORTED CONCOMITANT PART: UNKNOWN 2.4 MM SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7213389 ↗