BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 3120662 · Received May 20, 2013

    Report

    Report Number
    2520274-2013-02700
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. DEVICE IS 510K EXEMPT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURE DATES: 10/05/2006, 11/28/2006, AND 12/06/2006. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 57933 REVEALED THE TRAIL SPACER HANDLE, WAS MANUFACTURED BY (B)(4). SYNTHES RECEIVED THIS IN TWO PO NUMBERS AND TWO SYNTHES LOT NUMBERS. PO 674224, SYNTHES LOT 5347081, DATED 9/25/06 FOR (B)(4) PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 389IF151 REVISION B ON 9/25/06. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 9/21/06. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 10/5/06. PO 695480, SYNTHES LOT 5394908, DATED 11/24/06 FOR (B)(4) PART, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 389IF151 REVISION B ON 11/28/06. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 11/20/06. 1 PART WAS RELEASED TO THE WAREHOUSE ON 12/6/06. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED WITH A BROKEN TIP. MOST OF THE INNER SHAFT IS COATED WITH RUST SPOTS. THAN HANDLE SHAFT HAS WARE MARKS AT THE TOP AND IS LIGHTLY DISCOLORED. AVAILGN-NEMCOMED MANUFACTURED THE SPINDLE ASSEMBLY TRIAL SPACER HANDLE PN 03.802.151, LOT 2346515. 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 LENGTH WAS CONFIRMED TO BE WITHIN SPECIFICATION. MANUFACTURING DATES SHOULD BE 10/05/2006 AND 12/06/2006.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. PDE 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 DISPOSITION FOR THIS COMPLAINT FROM A DESIGN PERSPECTIVE IS VALID. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, BECAUSE OF TIGHTENING TOO TIGHT, THREADS ON CANULATED END OF INSTRUMENT BROKE INSIDE OF THE HANDLE OF THE TRIAL SPACER. NO EFFECT ON PATIENT, PROCEDURE WAS NOT DELAYED. THIS IS 1 REPORT OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222271 TRIAL SPACER HANDLE HTD SYNTHES MONUMENT 57933

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR