NA 311.46Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982187444), received between Apr 23, 2018 and May 31, 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2018, THE TAP FOR CORTEX SCREWS BROKE AND A PIECE OF THE TIP REMAINED INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. PATIENT STATUS IS STABLE. THIS REPORT IS FOR A TAP FOR 4.5 MM CORTEX/SHAFT SCREWS 130 MM/57 MM TAP DEPTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7557025 ↗
• MalfunctionApr 23, 2018Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING (OB-GYN) REVIEW OF FEMORAL OSTEOSYNTHESIS PROCEDURE ON (B)(6) 2018, SELF-TAPPING DEVICE BROKE DURING USE. THERE WAS NO DAMAGE TO THE PATIENT, THERE WAS NO INCREASE IN SURGICAL TIME. THERE WAS ONE MORE UNIT OF THE DEVICE AVAILABLE IN THE BOX, SO IT DID NOT DISRUPT THE SURGICAL PROCEDURE. THIS COMPLAINT INVOLVES ONE DEVICE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7452151 ↗