BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L115 TAN

    MDR report key: 7017951 · Received November 10, 2017

    Report

    Report Number
    9612488-2017-10570
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 16, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE MIA & INVESTIGATION SUMMARY INDICATES THAT: AS RECEIVED CONDITION OF DEVICE: 04.027.038S VISUAL INSPECTION: SIGNS OF USE ON THE BLADE, THE EDGE OF THE END CAP SHOWS STRONG DAMAGES. DHR NO FINDINGS MANUF EVAL: NO FINDINGS. THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL SYNTHES BAG. THE LASER MARKING WAS READABLE. THE BLADE WAS RECEIVED WITH THE INSTRUMENT (IMPACTOR) ASSEMBLED. TRACES OF USE WERE VISIBLE ON THE BLADE AND THE EDGE OF THE END CAP SHOWS STRONG TRACES. IN ORDER TO PERFORM MEASUREMENTS, THE BLADE WAS TAKEN OUT FROM THE INSTRUMENT, WHICH WAS EASY IF TURNED IN THE CORRECT DIRECTION. AS RELEVANT FOR THE COMPLAINT CONDITION; ¿WAS IMPOSSIBLE TO REMOVE THE BLADE FROM THE IMPACTOR¿ THE FOLLOWING FEATURES; THREAD (M7X1 BT LH) AND HEX (SW 4.5 F10 AND DEPTH) WERE IDENTIFIED AND MEASURED. THE RELEVANT DIMENSIONS WHERE ARE IMPORTANT THAT THE BLADE COULD REMOVE FROM THE INSTRUMENT WERE IDENTIFIED AND MEASURED. TWO DIMENSIONS FROM HEX HAVE FULFILLED THE SPECIFICATIONS. THE GAGE FOR THE THREAD HAS FAILED. THE REASON FOR THE FEATURE FAILED IS THAT THE THREAD HAS STRONG TRACES OF USE. THE THREAD FUNCTIONS WITH THE SCREW AND WITH THE INSTRUMENT (IMPACTOR FOR PFNA BLADE). THE PRODUCT WAS MANUFACTURED ACCORDING TO ITS SPECIFICATIONS; DURING THE MANUFACTURING PROCESS, THE LOTS (ENDCAP 9800734 /SCREW 9534455) WERE INSPECTED THROUGH THE INSPECTION SHEETS. THEY HAVE MEET ITS SPECIFICATIONS. THE RAW MATERIAL CERTIFICATE WAS CHECKED AND ALL USED RAW MATERIAL HAS FULFILLED THE SPECIFICATIONS. ON THE BASIS OF THE INVESTIGATION THE COMPLAINT IS NOT CONFIRMED, SINCE THE PRODUCTS IF TURNED IN THE CORRECT DIRECTION WERE EASY TO DISASSEMBLE. ACCORDING TO THE INVESTIGATION RESULTS AND FROM THE MANUFACTURING POINT OF VIEW THIS COMPLAINT IS RATED AS NOT VALID, SINCE NO MANUFACTURING ISSUE COULD BE FOUND. SINCE NO MANUFACTURING ISSUE WAS IDENTIFIED AND THIS COMPLAINT IS NOT VALID, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRA LINE IS NOT APPLICABLE. DEVICE 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

    (B)(4). DEVICE 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTERS PHONE NUMBER: (B)(6). THE 510K# IS UNKNOWN: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #04.027.038S / LOT #9662683. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25. SEPT. 2015 EXPIRY DATE: 01. SEPT. 2025. 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. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY IT WAS IMPOSSIBLE TO REMOVE THE BLADE FROM THE IMPACTOR. THE SURGERY WAS NOT PROLONGED. NO PATIENT HARM IS REPORTED. THIS COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800106 PFNA BLADE PERF L115 TAN APPLIANCE,FIXATION,NAIL/BLADE/ KTW SYNTHES BETTLACH 9662683

    Patients

    Seq Age Sex Outcome Treatment
    1