BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALFRING

    MDR report key: 5068835 · Received September 10, 2015

    Report

    Report Number
    2520274-2015-15790
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SYNFRAME HOLDING RING TWO-PIECE. FQP NOT REGISTERING, ADDITIONAL PRODUCT CODE: LXH. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS SEPTEMBER 28, 2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. DEVICE IS 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

    IT WAS DOCUMENTED ON OCTOBER 22, 2015 THAT THE PART HAD BEEN RETURNED TO THE INVESTIGATION SITE ON AUGUST 28, 2015. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE SET SCREW WAS MISSING. THE REPAIR TECHNICIAN REPORTED THE STOP SCREW WAS MISSING. MISSING PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: HEX SCREW M7 X 0.75, STOP SCREW. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF SERVICE AND REPAIR PROCESS. CORRECTED SERVICE HISTORY REVIEW (UPDATED PART NUMBER): 387.337 / LOT 3500558 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS SEPTEMBER 28, 2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    IT WAS REPORTED THAT SERVICE AND REPAIR DOCUMENTED THAT A SYNFRAME HOLDING RING TWO-PIECE IS MISSING A STOP SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600980 SYNFRAME HALFRING MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 3500558

    Patients

    Seq Age Sex Outcome Treatment
    1