BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 16094082 · Received January 4, 2023

    Report

    Report Number
    8030965-2023-00088
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 8, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. PART #:04.027.053S, LOT #:923P250, MANUFACTURING SITE:JABIL BETTLACH, RELEASE TO WAREHOUSE DATE:20/07/2022, EXPIRY DATE:01/07/2032. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE DEVICE WAS RECEIVED DISASSEMBLED, ALL OF THE COMPONENTS WERE RETURNED. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE PFNA-II BLADE L90 TAN WAS STRIPPED FROM THE THREADS OF THE SCREW. ADDITIONALLY, THERE ARE SIGNS OF SCRATCHING ALONG THE SURFACE OF ALL OF THE COMPONENTS MOST PROBABLY CREATED WHILE HANDLING THE DEVICE. THE PFNA II SURGICAL TECHNIQUE GUIDE DSEM-TRM-0714-0109-4 REV. LR WAS REVIEWED. FOLLOWING RELEVANT STATEMENTS WERE FOUND. INSTRUCTIONS OF USE: THE PFNA-II BLADE IS SUPPLIED IN A LOCKED STATE. 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. PRECAUTION: THE TIP OF THE PFNA-II BLADE MUST ROTATE FREELY AFTER ATTACHING IT TO THE IMPACTOR. THIS IS ESSENTIAL FOR THE IMPLANTATION OF THE PFNA-II BLADE. OTHERWISE REMOVE AND DISPOSE OF THE BLADE. DO NOT OVER TIGHTEN THE CONNECTION BETWEEN THE IMPACTOR AND THE PFNA-II BLADE. WHILE NO ROOT CAUSE CAN BE DETERMINED FOR THE REPORTED ISSUE, THE STRIPPING CONDITION OF THE SCREW WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES DURING LOCKING/UNLOCKING AND IMPLANTATION PROCESS. A DIMENSIONAL INSPECTION FOR THE PFNA-II BLADE L90 TAN WAS NOT PERFORMED SINCE IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PERFORMED, THE SCREW WAS FITTED INTO THE BLADE, FOLLOWED BY THE SLEEVE, WHEN TRYING TO ASSEMBLE THE SCREW WITH THE END CAP IT WAS NOT POSSIBLE TO ADVANCE THE CAP THROUGH THE THREADS, THE DEVICE WAS NOT ABLE TO BE ASSEMBLED AS A WHOLE, HENCE PROPERLY LOCKING WAS NOT REACHED. FUNCTIONAL ISSUES ARE MOST LIKELY DUE TO THE STRIPPED CONDITION OF THE THREADS OF THE SCREW. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PFNA-II BLADE L90 TAN WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED: THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: PFNA-II BLADE L75-L120MM, TAN REV. C / REV. C, DIMENSIONAL INSPECTION: N/A. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A TROCHANTERIC FRACTURE WITH THE PRODUCT IN QUESTION. THE SURGEON CONNECTED THE 90MM BLADE TO THE INSERTER AND INSERTED IT UNTIL IT HIT THE PROTECTION SLEEVE. THE SURGEON THEN TURNED THE BLADE CLOCKWISE WHILE PRESSING DOWN ON THE INSERTER TO LOCK THE BLADE, BUT IT DID NOT LOCK. THE GAP BETWEEN THE BLADE AND THE SHAFT WAS NOT FILLED WHEN CHECKED WITH THE IMAGE. THE 90MM BLADE WAS REMOVED AND REPLACED WITH AN 85MM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PFNA-II BLADE L90 TAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898616 PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH 923P250

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male UNK - INSERTION INSTRUMENTS: TRAUMA