BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 4856690 · Received June 19, 2015

    Report

    Report Number
    1719045-2015-10397
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Report Date
    June 5, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE CORRECTED TO UNKNOWN DUE TO REPORT FROM JDE. 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

    SERVICE HISTORY REVIEW: LOT #1221134 - NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN AND CANNOT BE TRACED. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE SCREWS WERE MISSING. THE REPAIR TECHNICIAN REPORTED MISSING PARTS AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: HEW SCREW M7 X 0.75, STOP SCREW. THIS ITEM WAS REPAIRED PER THE SERVICE MANUAL, PASSED SYNTHES FINAL INSPECTION, AND WAS RETURNED TO THE CUSTOMER ON JUNE 24, 2015. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 TWO SYNFRAME HALF RING DEVICES FAILED INSPECTION ROUTINE INSPECTION DUE TO BOTH PARTS MISSING A SCREW. THERE WAS NO REPORT OF PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 2 OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399407 SYNFRAME HALF RING MISC ORTHO SURGICAL INSTR LXH SYNTHES USA 1221134

    Patients

    Seq Age Sex Outcome Treatment
    1