BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L95 SST

    MDR report key: 7621456 · Received June 20, 2018

    Report

    Report Number
    8030965-2018-54454
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 25, 2018
    Report Date
    May 25, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819419889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 · 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 HISTORY RECORD (DHR) REVIEW: PART NUMBER: 02.027.034S; FRANCHISE LOT NUMBER: L830524; MANUFACTURING DATE/RELEASE TO WAREHOUSE DATE: APRIL 09, 2018; MANUFACTURING SITE: BETTLACH; EXPIRATION DATE: MARCH 01, 2028. NO RELEVANT NONCONFORMANCES WERE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: THE INVESTIGATION RESULT IS A SUMMARY FROM THE MANUFACTURING SIDE INVESTIGATION. THE BLADE IS JAMMED AND IT IS NOT POSSIBLE TO MEASURE THE FEATURES. THE FUNCTION BETWEEN THE BLADE AND THE SLEEVE IS OK BUT THE SCREW COULD NOT UNSCREWED FROM THE AND END CAP. THE SCREW JAMMED IN THE ENDCAP. DURING THE MANUFACTURING PROCESS THESE FEATURES WERE INSPECTED THROUGH THE INSPECTION SHEETS FOR SLEEVE, ENDCAP AND SCREW AND NO MANUFACTURING ISSUE WAS DETECTED FROM BALSTHAL SITE. THUS, THIS PRODUCT HAS PASSED ITS SPECIFICATIONS AND AFTER THE CHECKED WORK ORDERS THERE IS NO MANUFACTURING ISSUE FOUND. AS DISASSEMBLING WAS NOT POSSIBLE, PART HAS BEEN CUTTED. THE PARTS HAD TO BE CUT OPEN IN ORDER TO CARRY OUT AN ANALYSIS. THE FIRST PART WAS THE HEAD OF THE END CAP. AT THE HEAD PART WE COULD CHECK THE THREAD WITH THE THREAD GAUGE AND IT TURNED OUT THAT THE THREAD OF THE END CAP IS GOOD. THEN WE CUT THE PARTS IN HALF. WE HAVE NOTICED THAT THERE IS A MATERIAL DISTORTION AT THE HEAD OF THE SCREW. THIS IS AN INDICATION THAT THE SCREW WAS TURNED IN THE WRONG DIRECTION AND WITH MASSIVE PRESSURE. THEREFORE, A DISTORTION HAS FORMED AT THE HEAD OF THE SCREW AND THE THREAD HAS ALSO BEEN DAMAGED. WHEN TURNING IN THE RIGHT DIRECTION, THE SCREW IS FIXED IN THE END CAP. THUS, THE FUNCTION COULD NO LONGER BE OPERATED. THE DAMAGES ARE VISIBLE IN THE PICTURES. BASED ON THE TRACES INVESTIGATED WE FINALLY CONCLUDE A HANDLING ERROR. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    THERE IS NO PATIENT INVOLVEMENT. DEVICE WAS USED IN AN EDUCATIONAL SETTING WITH NO PATIENT INTERACTION, AND WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER AND EMAIL ADDRESS IS UNAVAILABLE. 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. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REMOVAL OF THE BLADE FROM THE IMPACTOR IS DIFFICULT AND WAS POSSIBLE ONLY WITH INCREASED EFFORT. THE ISSUE WAS DETECTED IN HOUSE, AT THE EDUCATION DEPARTMENT. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PFNA BLADE PERF L95 SST. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465155 PFNA BLADE PERF L95 SST ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L830524 07611819419889

    Patients

    Seq Age Sex Outcome Treatment
    1