BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX DISTRACTOR RACK

    MDR report key: 6103240 · Received November 15, 2016

    Report

    Report Number
    9680938-2016-10171
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Report Date
    October 24, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART #: 03.632.087, LOT #: T961458. MANUFACTURING DATE: JUN 24, 2011. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CTQ FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON JUN 23, 2011. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    THE MANUFACTURER INVESTIGATION IS AS FOLLOWS. THE RETURNED DISTRACTOR WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTRACTION PIN ON THE FIXED ARM WAS FOUND TO BE BROKEN, AT THE CONNECTING LASER WELD, AND THE OFFSET ARM WAS CRACKED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS METHOD OF USE AT THE TIME OF FAILURE IS UNKNOWN. THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESSIVE DISTRACTION FORCES. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. DEVICES WERE 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT IT WAS REPORTED A MATRIX DISTRACTOR RACK FROM AN EVALS SET WAS BROKEN. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION OF THE EQUIPMENT. THIS REPORT IS FOR ONE (1) MATRIX DISTRACTOR RACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752633 MATRIX DISTRACTOR RACK MISC. ORTHO SURGICAL INST. LXH SYNTHES TUTTLINGEN T961458

    Patients

    Seq Age Sex Outcome Treatment
    1