BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 7114326 · Received December 13, 2017

    Report

    Report Number
    8030965-2017-50631
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 15, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWA
    UDI-DI
    07611819349476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    : DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORD REVIEW. PART NUMBER: 03.010.410 . SYNTHES LOT NUMBER: 9120066. RELEASE TO WAREHOUSE DATE: 21.OCT.2014 . MANUFACTURING SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (IMPACTOR, PART NUMBER 03.010.410, LOT NUMBER 9120066). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE LASER WELD ON TOP OF THE HANDLE IS BROKEN. THEREFORE THE HANDLE IS SEPARATED FROM THE SHAFT. THE EVALUATION HAS SHOWN THAT THE DEVICE IS IN A USED CONDITION, THERE ARE MARKS OF HAMMER BLOWS VISIBLE AT THE SHAFT, ON THE BLUE HANDLE AND THE BOTTOM SIDE OF THE OVERHANG WITH THE ATTACH/LOCK MARKING. THE COMPLAINT IS CONFIRMED THE MOST PROBABLE ROOT CAUSE IS THAT THE DAMAGES AT THE BOTTOM SIDE OF THE INSTRUMENT LEAD TO THE BREAKAGE OF THE WELD. DUE TO OTHER COMPLAINTS OF THE SAME NATURE, APPROPRIATE RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE 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 RETURNED TO MANUFACTURER. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DATE RECEIVED BY MANUFACTURER WAS INADVERTENTLY REPORTED AS NOVEMBER 6, 2017 ON MEDWATCH REPORT (B)(4). THE CORRECT DATE SHOULD HAVE BEEN NOVEMBER 15, 2017. 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

    ADDITIONAL NARRATIVE: (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (510K): 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. 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 (B)(6) REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT THE BLUE PLASTIC ON THE HANDLE DETACHED FROM THE METAL DURING THE INSERTION OF THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE ON (B)(6) 2017. THERE IS NO REPORTED ADVERSE CONSEQUENCE FOR THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO OTHER MEDICAL INTERVENTION REQUIRED AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) IMPACTOR F/PFNA BLADE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893233 IMPACTOR F/PFNA BLADE IMPACTOR HWA OBERDORF SYNTHES PRODUKTIONS GMBH 9120066 07611819349476

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR