BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 7942706 · Received October 8, 2018

    Report

    Report Number
    8030965-2018-57054
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Report Date
    September 17, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819394223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. PART: 04.027.053S; LOT: L980518; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: JULY 20, 2018; EXPIRY DATE: JULY 01, 2028. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SELECTION: INVESTIGATION SITE: CQ ZUCHWIL , SELECTED FLOW(S): 2. DEVICE INTERACTION/FUNCTIONAL AND 3. DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED , VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE, IT CAN BE SEEN THAT THE HEXAGON SOCKET AT THE DISTAL END OF THE IMPLANT IS COMPLETELY WORN FROM USE, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. IN ADDITION, THE RECEIVED DEVICE SHOWS ON THE SURFACE SOME SINGS OF USE, OTHERWISE THE ARTICLE IS IN A GOOD CONDITION. FUNCTIONAL TEST: A FUNCTIONAL TEST IS NOT POSSIBLE BASED ON THE FOUND DAMAGE. THE REPORTED DEVICE WAS ASSEMBLED ACCORDING TO DRAWING, AND ALL PARTS WENT THROUGH A 100% FUNCTIONAL TEST, BEFORE THEY HAD LEFT THE PRODUCTION. DOCUMENT/SPECIFICATION REVIEW: DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DEVICE HISTORY RECORD (DHR) OF PRODUCTION LOT L980518. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT L980518. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DOCUMENT/SPECIFICATION REVIEW IS NEEDED. DIMENSIONAL INSPECTION: THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DIMENSIONAL INSPECTION IS NEEDED. SUMMARY: THERE IS NO PARTICULAR INFORMATION ON WHAT HAPPENED TO THIS ARTICLE BY THE CUSTOMER; UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE HAVE TO ASSUME THAT EXCESSIVE FORCE LED TO THIS DAMAGE OR/AND THAT OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE; ¿WHILE ATTACHING THE PFNA-II BLADE ON THE IMPACTOR, SCREW THE IMPACTOR COUNTERCLOCKWISE (NOTE THE MARK ¿ATTACH¿ ON THE IMPACTOR) INTO THE END OF THE PFNA-II BLADE TO UNLOCK THE BLADE. PUSH THE PFNA-II BLADE GENTLY TOWARDS THE IMPACTOR WHILE ATTACHING THE PFNA-II BLADE. DO NOT OVERTIGHTEN.¿ 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 · 0

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 0

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THERE WAS PATIENT OR SURGICAL INVOLVEMENT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON AN UNKNOWN DATE IT WAS NOTED THAT THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE WOULD NOT LOCK. IT IS NOT KNOWN IF THERE WAS PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783073 PFNA-II BLADE L90 TAN ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L980518 07611819394223

    Patients

    Seq Age Sex Outcome Treatment
    1