BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICAT OUT SHAFT

    MDR report key: 6667654 · Received June 26, 2017

    Report

    Report Number
    3003875359-2017-10303
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    May 29, 2017
    Report Date
    May 29, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    MAX
    UDI-DI
    07611819405813
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. ESTABLISHMENT NAME, ADDRESS, AND TELEPHONE NUMBER ARE UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER L161370. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 09.JAN.2017. 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. 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

    CUSTOMER QUALITY REVIEW OF THE RETURNED DEVICE: RECEIVED PART:1 X 03.812.001 / APPLICATOR OUTER SHAFT / LOT NUMBER L161370 AS RECEIVED CONDITION: THE COMPLAINED APPLICATOR OUTER SHAFT WAS RETURNED WITHOUT APPLICATOR INNER SHAFT (03.812.003) AND APPLICATOR KNOB (03.812.004). THE INTERLOCK PIN IS DAMAGED. FURTHERMORE THERE ARE SLIGHTLY TRACES OF USE CAN BE OBSERVED ON DEVICE'S SURFACE. CONCLUSION: OUR INVESTIGATION HAS SHOWN, THAT THE COMPLAINED APPLICATOR OUTER SHAFT WAS RETURNED WITHOUT APPLICATOR INNER SHAFT (03.812.003) AND APPLICATOR KNOB (03.812.004). THE INTERLOCK PIN IS DAMAGED. FURTHERMORE THERE ARE SLIGHTLY TRACES OF USE CAN BE OBSERVED ON DEVICE'S SURFACE. HOWEVER, BECAUSE OF THE DEVICE CONDITION THIS COMPLAINT IS RATED AS CONFIRMED. THE MANUFACTURING REVIEW OF BOTH DEVICES DOES SHOW THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AS INDICATED IN THE MANUFACTURING DOCUMENTS, THE CORRESPONDING INSPECTION SHEET CONFIRMS A 100% FUNCTIONAL CHECK DURING PRODUCTION. UNFORTUNATELY WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THIS HAPPENED. THE ARTICLE 03.812.001 WITH LOT NO L161370 WAS MANUFACTURED IN A QUANTITY OF 24 PIECES ON JANUARY 2017. WE ARE NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT ON THE ARTICLE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. FINALLY WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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

    IT WAS REPORTED THAT THE ORTHOKIT TECHNICIAN DETECTED THAT A SMALL PIECE OF THE APPLICATOR OUTER SHAFT DETACHED ITSELF FROM THE PRODUCT. NO PATIENT INVOLVEMENT. THE ISSUE WAS FOUND BY THE TECHNICIAN DURING THE CONTROL OF THE KIT, AFTER THE RETURN FROM THE HOSPITAL. SHIPPED TO (B)(6) NEXT WEEK. THIS COMPLAINT INVOLVES 1 PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447765 APPLICAT OUT SHAFT INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES HAGENDORF L161370 07611819405813

    Patients

    Seq Age Sex Outcome Treatment
    1