BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE ASSEMBLY FOR TRIAL SPACER HANDLE

    MDR report key: 3092622 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02344
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL INFORMATION; DEGENERATIVE DISK DISEASE. MANUFACTURING EVAL- (B)(4) MANUFACTURED THE SPINDLE ASSEMBLY TRIAL SPACER HANDLE PN 03.802.151, LOT 6581166. DUE TO AN UNKNOWN CAUSE, THE PRODUCT BROKE AT THE TIP OF THE THREADS. THE MATERIAL AND HARDNESS OF THE SHAFT WAS DETERMINED TO BE WITHIN SPECIFICATION. THE DIAMETER OF THE SHAFT WAS CONFIRMED TO BE WITHIN SPECIFICATION. BASED ON THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. PRODUCT DEVELOPMENT EVALUATION- THE FAILURE OCCURRED DUE TO INCOMPLETE THREAD ENGAGEMENT BETWEEN THE SPINDLE AND TRIAL. THE ROOT CAUSE MAY BE DUE TO USER ERROR OR MECHANICAL NONCONFORMANCE. THE RETURN DID NOT INCLUDE THE HANDLE AND SHAFT ASSEMBLY. WITHOUT THESE PARTS, THE CRITICAL DIMENSION OF SPINDLE-TRIAL ENGAGEMENT IS NOT KNOWN. FOR THESE REASONS, THE DISPOSITION FOR THIS COMPLAINT FROM A DESIGN PERSPECTIVE IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 6581166, (B)(4) PARTS, REVEALED THE TRIAL SPACER HANDLE WAS MANUFACTURED BY (B)(4). THE PARTS WERE INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 3/24/2011. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 4/8/2011. NO NON CONFORMITIES 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. DUE TO AN UNKNOWN CAUSE, THE PRODUCT BROKE AT THE TIP OF THE THREADS. THE MATERIAL AND HARDNESS OF THE SHAFT WAS DETERMINED TO BE WITHIN SPECIFICATION. THE DIAMETER OF THE SHAFT WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE ROOT CAUSE OF THIS COMPLAINT IS UNKNOWN.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, A TRIAL SPACER HANDLE BROKE. ALL THE PARTS WERE RECOVERED. THE TRIAL SPACER WAS REMOVED AND PLACED ON A NEW HANDLE. THIS RESULTED IN A TEN MINUTE DELAY IN THE SURGERY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194214 SPINDLE ASSEMBLY FOR TRIAL SPACER HANDLE LXH SYNTHES USA 6581166

    Patients

    Seq Age Sex Outcome Treatment
    1