BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/PFN+PFNA

    MDR report key: 7250343 · Received February 7, 2018

    Report

    Report Number
    8030965-2018-50937
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 16, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819280625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. UNKNOWN IF PATIENT WAS INVOLVED. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). UNKNOWN, DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 357.020, SYNTHES LOT NUMBER: 2110294, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 17. FEBRUARY 2005: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED INSERTION HANDLE FOR PFN AND PFNA (QTY. 1 / PART 357.020 / #LOT 2110294) WAS INSPECTED AT CUSTOMER QUALITY. THE ARTICLES ARE IN A USED CONDITION WITH SCRATCHES AND IMPRESSION MARKS ON THE SURFACES. ONE KNOB ON THE AIMING ARM IS BROKEN OFF. THE BROKEN OFF PORTION WAS NOT SENT BACK. BECAUSE OF THE DAMAGES THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. DHR REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. THE MEASURABLE DIMENSIONS ARE WELL DOCUMENTED AND ALL WITHIN THE VALID SPECIFICATIONS. INVESTIGATION/ CONCLUSION: BASED ON THE PROVIDED INFORMATION IT IS NOT EXACTLY CLEAR WHICH SCREW WAS MENTIONED. SINCE ONE KNOB ON THE AIMING ARM WAS BROKEN, WE ONLY CAN ASSUME THAT THE THUMB SCREW ON THE AIMING ARM COULD BE THE REASON FOR AN INSUFFICIENT CONNECTION (GUIDED AWAY THE SCREW) WITH THE INSERTION HANDLE. THEREFORE AND SINCE NO FURTHER INFORMATION IS AVAILABLE, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSERTION/AIMING ARM WAS GUIDED AWAY FROM THE SCREW. THIS COMPLAINT INVOLVES TWO PARTS. CONCOMITANT PARTS REPORTED: 1X UNK SCREW TRAUMA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92211 INSERT-HANDLE F/PFN+PFNA GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 2110294 07611819280625

    Patients

    Seq Age Sex Outcome Treatment
    1