BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

    MDR report key: 5003764 · Received August 14, 2015

    Report

    Report Number
    2530088-2015-10537
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 02/12/2009. PART #: 03.010.150, LOT# : 6083738 (NON-STERILE) - STAR/HEXDRIVE SCREWDRIVER T25 3.5 MM HEX/SELF- RETAINING. LOT WAS RELEASED TO THE WAREHOUSE ON 02/12/2009. NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED DEVICES ARE USED IN A VARIETY OF SYSTEMS INCLUDING LARGE FRAGMENT LCP AND SCREW EXTRACTION SYSTEMS. THE RETURNED STAR/HEXDRIVE SCREWDRIVER (03.010.150, 6083738) WAS RECEIVED WITH ITS TIP ROUNDED AT THE EDGES. DRAWINGS FOR THE DEVICES WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. THE ASSOCIATED DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITIONS. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. IT IS NOT POSSIBLE TO DETERMINE A TRUE ROOT CAUSE BUT BASED ON THE PROCEDURE IT IS POSSIBLE THAT THE SCREWDRIVER WAS USED TO REMOVE A SCREW WHICH WAS EMBEDDED IN DENSE BONE WHICH EXPOSED THE TOOL TO EXCESSIVE TORSIONAL FORCES AND CAUSED THE COMPLAINT CONDITIONS. ADDITIONALLY WEAR AND FATIGUE DUE TO REPETITIVE USE COULD HAVE ALSO CONTRIBUTED TO THE COMPLAINT CONDITIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REMOVAL OF A TITANIUM LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE ON (B)(6) 2015. WHEN THE SURGEON ATTEMPTED TO REMOVE TWO DIFFERENT SCREWS, TWO SEPARATE DEVICE HANDLES BROKE. IN ADDITION, THE END OF A SCREWDRIVER SHAFT BENT. ALSO, TWO ADDITIONAL SCREWDRIVER BROKE DURING THE PROCEDURE. AFTER THIRTY TO FORTY (30 TO 40) MINUTES, THE SCREWS WERE SUCCESSFULLY EXPLANTED WITH OTHER AVAILABLE INSTRUMENTS. IT WAS REPORTED THAT NO FURTHER INTERVENTION WAS REQUIRED AND THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538209 STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING SCREWDRIVERS HXX SYNTHES BRANDYWINE 6083738

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention