BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 5969815 · Received September 22, 2016

    Report

    Report Number
    3003875359-2016-10509
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE 4.0MM HEXAGONAL SCREWDRIVER (PART # 313.93, LOT # 8091250). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE 4.0MM HEXAGONAL SCREW DRIVER IS CHIPPED TOWARDS THE BASE OF THE WOODEN HANDLE. THE CHIP IS NEAR WHERE THE INSTRUMENT STARTS TO ROUND TOWARDS THE END. THIS COMPLAINT FOR RETURNED PART# 313.93 IS CONFIRMED, AS A "CHUNK" OF HANDLE IS MISSING FROM THE HANDLE EDGE ON THE RETURNED DEVICE. THE "CHUNK" OF MISSING HANDLE WAS NOT RETURNED BUT WOULD BE APPROXIMATELY 9MM BY 5MM AS MEASURED WITH CALIPERS AT CUSTOMER QUALITY (CQ). WHETHER THIS COMPLAINT CAN BE REPLICATED AT CQ IS NOT APPLICABLE. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THIS SCREWDRIVER IS AN INSTRUMENT USED TO INSERT AND REMOVE SCREWS THAT HAVE A 4.0MM HEXAGONAL DRIVE RECESS AND IS AVAILABLE FOR USE IN SEVERAL SYSTEMS INCLUDING THE 6.5/7.3 MM CANNULATED SCREW SYSTEM PER TECHNIQUE GUIDE. TOP LEVEL DRAWINGS WERE REVIEWED DURING THIS EVALUATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RECEIVED CONDITION IS CONSISTENT WITH THE RESULT OF MISHANDLING OF THE SCREWDRIVER (DROPPED ON FLOOR OR STRUCK BY ANOTHER DEVICE). IT IS MOST PROBABLE THAT THE METHOD OF USE RESULTED IN THE COMPLAINT CONDITION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(6). NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THE PIECE THAT SLIDES BACK AND FORTH FOR THE INTER-LOCK SCREWDRIVER IS BENT AND THE TIP IS A BIT TWISTED. THE 4.0MM HEXAGONAL SCREW DRIVER IS CHIPPED TOWARDS THE BASE OF THE WOODEN HANDLE. THE CHIP IS NEAR WERE THE INSTRUMENT STARTS TO ROUND TOWARDS THE END. BOTH DEVICES HAVE BEEN IN USE FOR AN UNKNOWN PERIOD OF TIME. THESE EVENTS WERE DISCOVERED OUTSIDE OF THE OPERATING ROOM, THERE IS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR COM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622345 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES HAGENDORF 8091250

    Patients

    Seq Age Sex Outcome Treatment
    1