BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUPLING SCREW FOR EXTRACTION OF DHS BLADES

    MDR report key: 6280328 · Received January 26, 2017

    Report

    Report Number
    9612488-2017-10038
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    December 13, 2016
    Report Date
    January 9, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWB
    UDI-DI
    10886982076991
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. ARTICLE 03.224.008 LOT 2243209. THE INVESTIGATION OF THE RETURNED CONNECTING SCREW HAS SHOWN THAT THE THREADED TIP IS BROKEN OFF AS COMPLAINED. THE ITEM SHOWS SOME WEAR MARKS AND SCRATCHES AT THE SURFACE. AN EXACT CAUSE LEADING TO THE BREAKAGE WAS NOT ABLE TO BE DETERMINED. IT CAN BE ASSUMED THAT TOO MUCH APPLIED MECHANICAL FORCE CAUSED THIS DAMAGE. ONE OF THE OTHER REASONS FOR THE BREAKAGE MAY HAVE BEEN INSUFFICIENT CONNECTION WITH THE INSERTER. IF THE CONNECTION IS NOT TIGHT, THE FORCES WHILE HAMMERING MAY CAUSE THE BREAKAGE OF THE THREADED TIP. THE MEASUREMENT OF THE RELEVANT DIMENSION HAS SHOWN NO DEVIATION TO THE SPECIFICATION. ADDITIONALLY, IT WAS FOUND THAT THE CONNECTING SCREW WAS MANUFACTURED IN FEBRUARY 2007. AS THIS INSTRUMENT IS ALREADY MORE THAN 10 YEARS OLD, IT CANNOT BE RULED OUT THAT THE DAMAGES WERE CAUSED DUE TO WEAR AND TEAR OVER THE YEARS. TO POINT OUT TO THE SURGICAL TECHNIQUE IT IS IMPORTANT THAT THE WRENCH AND CONNECTING SCREW MUST FIT THE DHS SCREW EXACTLY. THE CONNECTING SCREW MUST BE TIGHTENED SECURELY. AFTER REMOVING THE DHS PLATE, PLACE THE CONNECTING SCREW THROUGH THE CANNULATION OF THE EXTRACTION INSTRUMENT AND FIX IT TO THE DHS BLADE. THE BLADE IS THEN REMOVED WITH SOFT BACKWARD SLIDE HAMMERING ON THE EXTRACTION INSTRUMENT. MEASUREMENT OUTER DIAMETER Ø4.0 PER DRAWING. GAGE: (B)(4). TOLERANCE Ø4.0 +0 / -0.1. RESULT: Ø3.95 "PASS". NO PRODUCT FAULT COULD BE DETECTED. 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 WEIGHT IS NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.224.008, LOT# 2243209. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEB 20, 2007. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT THE TIP OF A CONNECTING SCREW FOR EXTRACTION OF DYNAMIC HIP SCREW (DHS) BLADE BROKE OFF INTRAOPERATIVE ON (B)(6) 2016. THE DHS BLADE COULD NOT BE REMOVED AND WAS LEFT INTO PATIENT'S BODY. NO PROLONGATION OF SURGERY WAS REPORTED, NO INFORMATION ABOUT PATIENT OUTCOME WAS REPORTED. REPORTED CONCOMITANT DEVICES: DHS PLATE (QUANTITY 1). DHS LOCKING SCREW (QUANTITY 1). CORTICAL SCREW (QUANTITY 1). THIS REPORT IS FOR ONE (1) COUPLING SCREW FOR EXTRACTION OF DHA BLADES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE 27 JAN 2017: FRAGMENTS WERE GENERATED, BUT IT'S UNKNOWN, WHETHER IT WAS EASY OR DIFFICULT TO REMOVE THEM. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63367 COUPLING SCREW FOR EXTRACTION OF DHS BLADES EXTRACTOR HWB SYNTHES BETTLACH 2243209 10886982076991

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ONE (1) UNKNOWN CORTICAL SCREW| ONE (1) UNKNOWN DHS LOCKING SCREW| ONE (1) UNKNOWN DHS PLATE