BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø11 XS 125° L170 TAN

    MDR report key: 6912438 · Received October 3, 2017

    Report

    Report Number
    9612488-2017-10505
    Event Type
    Injury
    Date Received
    October 3, 2017
    Report Date
    September 15, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT WAS SCHEDULED FOR REMOVAL ON (B)(6) 2017; HOWEVER IT IS UNKNOWN IF THE REVISION WAS PERFORMED AND THE DEVICE WAS EXPLANTED ON (B)(6) 2017. DEVICE RETURNED TO MANUFACTURER. A MANUFACTURING INVESTIGATION WAS PERFORMED. THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL SYNTHES BAG. THE LASER MARKING WAS READABLE. TRACES OF USE WERE VISIBLE AND THE NAIL IS BROKEN IN THE REGION OF THE CITRUS SHAPE. AS RELEVANT FOR THE COMPLAINT CONDITION; NAIL BROKEN, THE FOLLOWING FEATURES; OUTER DIAMETER (16.5MM) AS WELL AS INNER DIAMETER (4.4MM) WERE IDENTIFIED AND MEASURED. THE RELEVANT DIMENSIONS WERE MEASURED NEAR OF THE BROKEN REGION AND THEY HAVE FULFILLED THE SPECIFICATIONS. THE CITRUS SHAPE, WHERE THE NAIL WAS BROKEN, COULD NOT BE MEASURED. DURING MANUFACTURING THE DIMENSION OF THE HOLE WAS 100% CHECKED WITH A GO/NO GO GAGE AND HAVE FULFILLED ITS SPECIFICATIONS. NO MANUFACTURING ERROR FOUND. PRODUCT WAS MANUFACTURED ACCORDING TO ITS SPECIFICATIONS. THE RAW MATERIAL CERTIFICATES WERE CHECKED AND THE USED RAW MATERIAL HAS FULFILLED THE SPECIFICATIONS. BESIDES, DURING THE MANUFACTURING PROCESS THE LOT (L102369) WAS INSPECTED THROUGH THE RELEVANT INSPECTION SHEET AND HAVE MEET ITS SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS, THIS COMPLAINT IS CONFIRMED SINCE THE NAIL IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, THIS COMPLAINT IS RATED AS NOT VALID BECAUSE THE RELEVANT DIMENSIONS OF THE NAIL WERE MEASURED AS WELL AS THE RELEVANT MANUFACTURING DOCUMENTATION RELATED TO THE ARTICLE (472.102S) WAS REVIEWED AND NO MANUFACTURING ISSUE COULD BE FOUND. SINCE NO MANUFACTURING ISSUE WAS IDENTIFIED AND THIS COMPLAINT IS NOT VALID. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF POSTOPERATIVE NAIL BREAKAGE IS UNKNOWN. (B)(4). IMPLANT WAS SCHEDULED FOR REMOVAL ON (B)(6) 2017; HOWEVER IT IS UNKNOWN IF THE REVISION WAS PERFORMED AND THE DEVICE WAS EXPLANTED ON (B)(6) 2017. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 472.102S, LOT # L102369: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 06.SEP.2016 EXPIRY DATE: 01.AUG.2026: NO NON-CONFORMANCE REPORTS (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. 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)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DEVICES WERE USED IN THE SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2017. FOUR MONTHS AFTER THE SURGERY, IT WAS FOUND BY THE X-RAY IMAGES THAT THE NAIL HAD BEEN BROKEN AT THE BLADE INSERTION POINT. REHABILITATION WAS STOPPED AND NON-WEIGHT BEARING WAS ORDERED BY THE SURGEON. ON (B)(6) 2017, THE PATIENT IS SCHEDULED TO HAVE A REVISION SURGERY (SWITCHING FROM PFNA EXTRA SMALL TO TFNA LONG). CONCOMITANT DEVICES: PFNA-II BLADE L100 TAN (PART # 04.027.055S, LOT # 9695723, QUANTITY 1), BOLT Ø4.9 SELF-TAP L34 TAV GREEN (PART # 459.340VS, LOT # 5941258, QUANTITY 1), PFNA-II END CAP EXTENS. 0 TAN (PART # 473.170S, LOT # L307231, QUANTITY 1). THIS REPORT IS FOR ONE (1) PFNA-II Ø11 XS 125° L170 TAN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690953 PFNA-II Ø11 XS 125° L170 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH L102369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention