BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM

    MDR report key: 7335938 · Received March 13, 2018

    Report

    Report Number
    8030965-2018-52021
    Event Type
    Injury
    Date Received
    March 13, 2018
    Report Date
    February 19, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819012721
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 280.900, LOT# 9913963. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: APR 08, 2016. 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. PRODUCT INVESTIGATION WAS COMPLETED. THE INVESTIGATION HAS SHOWN THAT THE DHS/DCS® SCREW WAS BROKEN AS COMPLAINED. THE BREAKAGE OCCURRED IN THE MIDDLE OF THE SCREW SHAFT, WHERE THE INNER DIAMETER CHANGES ITS DIMENSION. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS IMPLANT WAS MANUFACTURED IN (B)(6) 2016 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE RELEVANT DIMENSIONS WERE CHECKED AND FOUND TO BE IN ACCORDANCE WITH THE TECHNICAL DRAWING. INNER DIAMETER- SHAFT IS 2.72MM (SPEC 2.7MM +/-0.1MM,) INNER DIAMETER- THREADED TIP IS 3.73MM (SPEC 3.75 +/- 0.1MM), OUTER DIAMETER ¿ TWO FLAT AREA IS 7.11MM (SPEC 7.15MM +0/-0.08MM). THE MATERIAL OF THE DHS/DCS® SCREW IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS FOR IMPLANTS MADE OF STAINLESS STEEL (ISO 5832-1). REVIEW OF RAW MATERIAL CERTIFICATE INDICATES THAT MATERIAL CONFORMS TO SPECIFICATIONS. BASED ON THE REVIEW OF PROVIDED X-RAY, SCREW BREAKAGE COULD BE CONFIRMED. THE INVESTIGATION FOUND NO PRODUCT RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION; A MATERIAL OR MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. THE INFORMATION IN THIS COMPLAINT RECORD REASONABLY SUGGESTS THAT THE CAUSE OF FAILURE IS DUE TO PATIENT¿S FALL. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    PATIENT ID AND WEIGHT WERE NOT PROVIDED FOR REPORTING. EXACT DATE OF EVENT IS UNKNOWN. DATE OF IMPLANT IS UNKNOWN. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THREE YEARS POST-OPERATIVELY, IN (B)(6) 2017, THE PATIENT FALL AND THE IMPLANTED FEMORAL NECK SCREW BROKE. THE IMPLANT WAS SUCCESSFULLY REMOVED ON (B)(6) 2018. PATIENT AND SURGERY OUTCOME WERE NOT REPORTED. CONCOMITANT DEVICES REPORTED: 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM (PART# 281.102, LOT# L119574, QUANTITY 1), 4.5MM CORTEX SCREW SELF-TAPPING 38MM (PART# 214.838, LOT# 9750962, QUANTITY 1), 4.5MM CORTEX SCREW SELF-TAPPING 40MM (PART# 214.840, LOT# 9757515, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176877 DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9913963 07611819012721

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention