BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROKEN SCREW EXTRACTOR HEX COUPLING

    MDR report key: 4537044 · Received February 23, 2015

    Report

    Report Number
    1719045-2015-10123
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    February 10, 2015
    Report Date
    February 10, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT S.S. WHITE MEDICAL PRODUCTS, INC. MANUFACTURED THE BROKEN SCREW EXTRACTOR, P/N (B)(4), AND LOT #6023369 (SUPPLIER LOT #016779) ON PO #(B)(4) FOR (B)(6) PIECES DELIVERED (B)(6) 2008. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED (B)(6) 2008 AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET #(B)(6). THE PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(6) 2008. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE 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

    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

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE TWO BROKEN SCREW EXTRACTORS WAS LIKELY CAUSED BY OVER SIX YEARS OF USE; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. PART 03.505.222 SCREW EXTRACTOR IS AN INSTRUMENT ROUTINELY USED IN THE UNIVERSAL SCREW REMOVAL SET. THE DEVICES WERE RETURNED AND REPORTED TO HAVE BROKEN WHILE REMOVING A SCREW DURING SURGERY. THIS CONDITION IS CONFIRMED; ONE OF THE DISTAL PRONGS OF THE EXTRACTOR ON BOTH DEVICES HAS SHEARED OFF. IT IS LIKELY THAT OVER SIX YEARS OF USE HAS LED TO THIS COMPLAINT CONDITION. THE BALANCE OF EACH DEVICE IS IN GOOD CONDITION. BOTH DEVICES WERE MANUFACTURED IN NOVEMBER 2008 AND ARE OVER SIX YEARS OLD. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERMAXILLARY FIXATION PROCEDURE USING THE IMF SCREW SET, TWO SCREW HEADS BROKE OFF DURING INSERTION INTO THE PATIENT. THEN WHEN USING THE UNIVERSAL SCREW BROKEN SCREW EXTRACTORS, THE TIP OF THE EXTRACTOR BROKE OFF, THE BROKEN IMF SCREWS WERE REMOVED FROM THE PATIENT . LATER THE 2.4 THREADED REDUCTION TOOL THE SELF DRILLING TIP BROKE OFF. THIS TIP REMAINS IN THE PATIENT. SURGERY WAS COMPLETED WITH ABOUT A FIVE MINUTE TIME DELAY. THIS IS REPORT 3 OF 5 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125632 BROKEN SCREW EXTRACTOR HEX COUPLING EXTRACTOR HWB SYNTHES MONUMENT 016779

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR