NA 03.025.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982069818), received between Mar 2, 2017 and Mar 2, 2017 — classified as 1 injury.

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.

• InjuryMar 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLOSED REDUCTION INTRAMEDULLARY NAILING SURGERY OF A FRACTURED HUMERUS ON (B)(6) 2017 THE SURGEON VIOLATED THE BRACHIAL ARTERY WHILE USING A DRILL/REAMER FROM A SYNTHES SET. UPON DISTAL LOCKING OF THE NAIL, THE SURGEON DAMAGED THE ARTERY WITH A 2.9MM/5.0MM DRILL-REAMER FOR USE WITH THE 4.0MM ANGULAR STABLE LOCKING SCREW SYSTEM. PATIENT WAS EXPERIENCING A LARGE QUANTITY OF BLOOD LOSS. THE SURGEON WAS ABLE TO TEMPORARILY CONTROL BLOOD LOSS WITH SURGICAL INSTRUMENTATION FROM THE HOSPITAL INSTRUMENT TRAY. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED; A VASCULAR SURGEON WAS REQUIRED TO REPAIR THE VESSEL. THE SURGEON COMPLETED THE IM NAILING PROCEDURE PRIOR TO THE REPAIR OF THE BLOOD VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY WAS REPORTED. PATIENT STATUS IS STABLE. CONCOMITANT DEVICES: NAIL, UNKNOWN PART/UNKNOWN LOT, QTY 1. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6373988 ↗