BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 4821652 · Received June 5, 2015

    Report

    Report Number
    2530088-2015-10468
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    March 30, 2015
    Report Date
    May 14, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ONE OF THE FOLLOWING DEVICE(S) WAS RECEIVED: CANNULATED HEXAGONAL SCREWDRIVER FOR 7.3MM CANNULATED SCREW (PART # 314.050 / LOT # A4EE385 / MFG. DATE: 09/1995) THE BROWN HANDLE HAS MINOR MARKS FROM ROUTINE USE, AND THE DISTAL TIP IS COMPLETELY DESTROYED AND BROKEN OFF THE DEVICE. THE TIP WAS RETURNED WITH THE DEVICE. IT IS UNKNOWN WHAT CAUSED THE COMPLAINT CONDITION, BUT IT IS LIKELY THAT ACCUMULATED WEAR AND EXCESSIVE TORQUE WAS APPLIED TO THE INSTRUMENT CAUSING THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION, THIS COMPLAINT IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW - THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN ATTEMPTING TO TIGHTEN THE SCREW THE VERY TIP OF THE SCREWDRIVER BROKE OFF THE SHAFT ¿ ALL PIECES WERE RETRIEVED FROM THE PATIENT STAYED ON THE END OF THE GUIDE WIRE SO THE SURGEON WAS ABLE TO PULL IT OFF THE GUIDE WIRE. NO ADDITIONAL INTERVENTION ¿ X-RAYS TAKE TO DETERMINE THAT NO FOREIGN PIECES REMAINED IN THE PATIENT. ANOTHER SCREWDRIVER WAS AVAILABLE TO FINISH THE CASE. THERE WAS A ONE MINUTE SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS FINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364703 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVER HXX SYNTHES BRANDYWINE A4EE385

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention