BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L100 TAN

    MDR report key: 6645284 · Received June 15, 2017

    Report

    Report Number
    9612488-2017-10271
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 26, 2017
    Report Date
    May 29, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS PERFORMED. WE HAVE RECEIVED THE COMPLAINED BLADE IN UNLOCKED CONDITION. SIGNS OF USAGE AT THE CONNECTING AND SHAFT ARE VISIBLE. A FUNCTIONAL TEST HAS SHOWN THAT THE IMPLANT IS WORKING AS INTENDED. THE BLADE IN QUESTION COULD BE LOCKED AND UNLOCKED AS FORESEEN. WE WERE NOT ABLE TO REPRODUCE THE COMPLAINED PROBLEM. BASED ON THIS THE COMPLAINT IS RATED AS UNCONFIRMED, AND NOT VALID FROM THE MANUFACTURING POINT OF VIEW. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THERE IS NO PARTICULARIZE INFORMATION WHAT'S HAPPENED TO THIS ARTICLE BY CUSTOMER, BASED ON THIS WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS REPORTED PROBLEM, BUT WE HAVE TO ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. CORRECTED DATA: UDI: (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. 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. (B)(6). 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: 04.027.035S LOT 141233. THE CORRECT LOT NUMBER IS L141233. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 27 SEPTEMBER 2016 / EXPIRY DATE: 01 SEPTEMBER 2026. 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 THE PFNA BLADE COLD NOT BE CLOSED. THIS HAPPENED INTRAOPERATIVE. PATIENT OUTCOME IS EXCELLENT. SURGERY SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425033 PFNA BLADE PERF L100 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH L141233

    Patients

    Seq Age Sex Outcome Treatment
    1