BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME RING CLAMP

    MDR report key: 4851108 · Received June 17, 2015

    Report

    Report Number
    3003875359-2015-10293
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Report Date
    June 5, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW - MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 18. JAN. 2008. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 387.347, LOT NUMBER 1798624, SYNFRAME RING CLAMP). THE SUBJECT DEVICE WAS RETURNED FOR THE COMPLAINT CONDITION OF ¿THE SYNFRAME RING CLAMP IS RUNNING OFF AND IS NOT HOLDING RING FIRMLY.¿ UPON RECEIPT OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE COULD BE TIGHTENED FULLY. THE DEVICE SHOWS SIGNS OF WEAR. THERE ARE MARKINGS AND UNEVEN WEAR ON THE OUTER EDGES WHERE THIS DEVICE WOULD ATTACH TO THE RING, INDICATING THAT THIS WAS PLACED ON THE INNER RADIUS OF THE RING, INSTEAD OF THE OUTER RADIUS WHERE IT IS MEANT TO SNAP ONTO. BASED ON THIS OBSERVATION, IT IS POSSIBLE THAT THIS DEVICE WAS BEING USED INCORRECTLY AND AS A RESULT COULD NOT FULLY TIGHTEN ONTO THE RETRACTOR. THE DRAWINGS WERE REVIEWED FOR THIS PART AND WERE FOUND TO BE ADEQUATE IN DESIGN AND MATERIALS FOR THE INTENDED USE OF THIS DEVICE. AS PREVIOUSLY REPORTED, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THIS COMPLAINT COULD NOT BE CONFIRMED. 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 SIX (6) SYNFRAME RING CLAMPS WERE RUNNING OFF AND ARE NOT HOLDING RING FIRMLY. IT WAS ALSO REPORTED THAT TWO BLADES WERE BENDING AT THE ARM INTERFACE. IT WAS REPORTED THAT THE SURGEON MENTIONED IN PASSING THAT SOME OF THE RING CLAMPS WERE NOT HOLDING THE RING FIRMLY AND THAT SOME OF THE BLADES WERE BENDING. THE SALES CONSULTANT WENT THROUGH THE SET AND PULLED OUT THE PARTS THAT WERE NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THIS COMPLAINT INVOLVES 8 DEVICES. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393695 SYNFRAME RING CLAMP MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1798624

    Patients

    Seq Age Sex Outcome Treatment
    1