BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 9897585 · Received March 30, 2020

    Report

    Report Number
    8030965-2020-02399
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 2, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819109216
    PMA / PMN Number
    K993314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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

    THE VISUAL INSPECTION OF THE RETURNED SYNFRAME HALF RING HAS SHOWN THAT THE LOCKING SCREW IS DAMAGED AT THE THREADED SHAFT AS WELL THE HEXAGONAL RECESS IS BADLY WIDENED. ALL IN ALL THE DEVICE IS IN VERY USED CONDITION AND THERE ARE WEAR MARKS AND SCRATCHES VISIBLE ALL OVER THE SURFACE. A FUNCTIONAL TEST CANNOT BE PERFORMED OF THE DETECTED DAMAGE. THE DAMAGED THREAD OF THE LOCKING SCREW PREVENT A PROPER TIGHTENED OF THE CONNECTION WITH THE OTHER SYNFRAME HALF RING. THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT THEREFORE IS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT THE LOCKING SCREW IS DAMAGED AT THE THREADED SHAFT AS WELL THE HEXAGONAL RECESS IS BADLY WIDENED. ALL IN ALL THE DEVICE IS IN VERY USED CONDITION AND THERE ARE WEAR MARKS AND SCRATCHES VISIBLE ALL OVER THE SURFACE. THE DAMAGED THREAD OF THE LOCKING SCREW PREVENT A PROPER TIGHTENED OF THE CONNECTION WITH THE OTHER SYNFRAME HALF RING. THE DAMAGE INCURRED IS DETERMINED TO BE POST PRODUCTION. THE DAMAGED LOCKING SCREW IS A CLEAR INDICATION, THAT THE PRODUCT WAS USED IN AN EXCESSIVE WAY OVER THE YEARS. WE DO SUPPOSE THAT THE CAUSE OF THE DAMAGES ARE THE RESULT OF A SEVERAL MECHANICAL OVERLOAD SITUATION DURING USE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS "DIMENSIONAL INSPECTION:" ARE NOT REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE HISTORY LOT PART: 50131166 LOT: 1941932 MANUFACTURING SITE: (B)(4) RELEASE TO WAREHOUSE DATE: 08. JULY. 2008 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SYNFRAME SENT HAD A DAMAGED PART ON IT. THE SYNFRAME HAS A LARGE RING WHICH IS HELD TOGETHER BY SCREWS ON ITS DIAMETER. THERE IS AN ISSUE WITH THE LOCKING SCREWS THAT MEANS THE RING WAS NOT STABLE DURING USE. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364393 SYNFRAME HALF RING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH OBERDORF SYNTHES PRODUKTIONS GMBH 1941932 07611819109216

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNFRAME HOLDING RING Ø300 2PART CPL