BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS COUPLING SCREW

    MDR report key: 5679257 · Received May 25, 2016

    Report

    Report Number
    3003875359-2016-10316
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    April 25, 2016
    Report Date
    May 3, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. THE INFORMATION AVAILABLE INDICATES THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION; THEREFORE, THERE IS NO REASON TO BELIEVE FRAGMENTS WERE RETAINED BY THE PATIENT. THIS REPORT WILL BE CATEGORIZED AS A MALFUNCTION. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JANUARY 8, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    PRODUCT INVESTIGATION SUMMARY: THE INVESTIGATION HAS SHOWN THAT THE THREADED TIP IS BROKEN OFF AS COMPLAINED. THE BROKEN OFF PART IS STILL IN THE DHS/DCS SCREW. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS CONNECTING SCREW WAS MANUFACTURED IN JANUARY, 2015 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. UNFORTUNATELY, THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED. PLEASE NOTE, TO PREVENT SUCH OCCURRENCE, AND TO ENSURE A CORRECT LOAD TRANSFER, IT IS CRUCIAL TO HAVE AN APPROPRIATE CONNECTION BETWEEN THE DHS-SCREW AND THE CONNECTING SCREW, WHICH IS GUIDED THROUGH THE APPROPRIATE DHS/DCS WRENCH. THIS CONNECTING SCREW IS DESIGNED FOR INSERTION PROCEDURES ONLY. NEVER USE THE INSERTION INSTRUMENTS FOR IMPLANT REMOVAL. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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 FOLLOWS: IT WAS REPORTED THAT THE TIP OF A CONNECTING SCREW BROKE OFF DURING A SURGICAL PROCEDURE ON (B)(6) 2016. THE BROKEN PORTION REMAINED IN THE DYNAMIC HIP SCREW (DHS) FOLLOWING THE BREAKAGE. THE SURGERY WAS PROLONGED APPROXIMATELY TWELVE (12) MINUTES. THE PATIENT'S POST-OPERATIVE STATUS WAS REPORTED AS GOOD. CONCOMITANT DEVICES REPORTED: DYNAMIC HIP SCREW (PART 280.850S / LOT 9800341 / QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333924 DHS/DCS COUPLING SCREW EXTRACTOR HWB SYNTHES HAGENDORF 9265717

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR