BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER T8 CYLINDRIC W/GROOVE SHAFT Ø3

    MDR report key: 7025799 · Received November 13, 2017

    Report

    Report Number
    3003875359-2017-10557
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Report Date
    October 19, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    07611819162785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE INVESTIGATION SUMMARY INDICATES THAT: RECEIVED PART: 1 X 313.302, SCRDRIVER T8 CYLINDRIC W/GROOVE SHAFT Ø3, LOT NO: 8143381. CONCLUSION: OUR INVESTIGATION HAS SHOWN THAT THE TIP OF THE SCREWDRIVER IS BROKEN. THE BROKEN TIP IS MISSING. THE REMAINING PART IS SERIOUSLY TWISTED IN DIRECTION CONSISTENT WITH SCREW REMOVAL. THE MANUFACTURING REVIEW DOES SHOW THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATERIAL AND HARDNESS CONFORMITY WAS CHECKED ON THE SEMI-FINISHED PART 50151163, WHICH IS A SUB-COMPONENT OF 313.302. FOLLOWING WORK ORDERS ((B)(4)), WHICH WERE PRODUCED IN THE TIME FRAME FROM SEPTEMBER 5TH 2012 TO SEPTEMBER 24TH 2012, WERE CHECKED WITH THE RESULT THAT THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS CORRECT AT TIME OF MANUFACTURING. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE DUE TO MISSING DETAILED CLINICAL INFORMATION AND MISSING BROKEN PART. WE SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE ARTICLE 313.302 WITH LOT NO 8143381 WAS MANUFACTURED IN A QUANTITY OF (B)(4) PIECES ON NOVEMBER 2012. WE ARE NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT ON THE ARTICLE. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 313.302, LOT # 8143381: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 14. NOV. 2012: NO NON-CONFORMANCE REPORTS (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. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER HEAD HAS STRIPPED. IT NO LONGER ENGAGES WITH SCREWS AND COULD NOT REMOVE THE SCREWS REQUIRED IN THE SURGERY. THIS SCREWDRIVER WAS RELATIVELY NEW AND HAD ONLY BEEN USED IN A COUPLE OF CASES. IT WASN¿T DAMAGED DURING THE SURGERY WHICH WAS ON (B)(6) 2017 BUT SUSPECTED TO HAVE BEEN DAMAGED PREVIOUSLY, JUST NOT PICKED UP BY STERILE SERVICES. THERE WAS SURGICAL DELAY OF TWO (2) HOURS DUE TO HAVING TO GET AN ALTERNATIVE KIT FROM OTHER HOSPITAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS THEY USED AN ALTERNATIVE INSTRUMENT. CONCOMITANT PARTS REPORTED: SCREW . THIS REPORT IS FOR ONE (1) SCRDRIVER T8 CYLINDRIC W/GROOVE SHAFT Ø3. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805578 SCRDRIVER T8 CYLINDRIC W/GROOVE SHAFT Ø3 SCREWDRIVERS HXX SYNTHES HAGENDORF 8143381 07611819162785

    Patients

    Seq Age Sex Outcome Treatment
    1