BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM

    MDR report key: 3864980 · Received June 11, 2014

    Report

    Report Number
    0009610622-2014-00271
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION REVEALED BOTH SET SCREWDRIVERS TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. ACCORDING TO ADDITIONAL INFORMATION RECEIVED ONLY ONE OF THE SCREWDRIVERS WAS INVOLVED IN THE EVENT REPORTED, BUT THE CUSTOMER COULD NOT IDENTIFY THE DEVICE, WHICH WAS APPLIED DURING THE EVENT REPORTED. REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE EVENT OF WORN SILICONE COATING OR CUTS AND PEELING OFF RESPECTIVE LOOSENING OF THE MATERIAL IN THE UPPER AND MIDDLE AREA MOST LIKELY HAPPEN DUE TO CONTACT OF THE SILICONE COVER WITH THE METALLIC PART OF THE TARGET DEVICE, WHEREAS DAMAGES IN THE LOWER AREA MOST LIKELY OCCUR DUE TO CONTACT OF THE SILICONE COVER WITH A DAMAGED NAIL HOLDING SCREW. A PRE-DAMAGE COULD ALSO HAVE BEEN INDUCED BY CUTS WITH A SCALPEL. THE INVESTIGATION REVEALED FURTHERMORE THAT THE CLAMPING FUNCTION OF BOTH SET SCREWDRIVERS RETURNED IS NOT GIVEN DUE TO A NOT INTENDED PLACED CLAMPING RING AT THE TIP OF THE HEXAGON. THE EDGES AT THE TIP OF THE HEXAGON ARE SLIGHTLY DEFORMED. THUS WE ASSUME THAT A FADING OF THE CLAMPING PROPERTY HAD BEEN ARISEN OVER TIME OF USE DUE TO MULTIPLE INTRA-OPERATIVE OBLIQUE INSERTIONS INTO A SET SCREW. THIS IS REGARDED AS COLLATERAL FINDING AND WAS NOT REPORTED IN THE INQUIRY. THIS DEVICES RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND AS THEY HAD BEEN IN USE FOR A LONGER TIME (BOTH MANUFACTURED IN 2007) WE PRE-SUPPOSE THAT THE SET SCREWDRIVERS HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE COVER ON A 1320-0231 BROKE APART WHILST INSERTING A SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE COVER ON A (B)(4) BROKE APART WHILST INSERTING A SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344812 SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM INSTRUMENT HXX STRYKER TRAUMA KIEL K533630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other