BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L95 TAN

    MDR report key: 6821703 · Received August 25, 2017

    Report

    Report Number
    9612488-2017-10435
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 26, 2017
    Report Date
    August 2, 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. UDI: (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INITIAL REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. MFG DATE: A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY PENDING COMPLETION. 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.

    Additional Manufacturer Narrative · 1

    DHR REVIEW WAS COMPLETED. 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. MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: 18.MAY.2017, EXPIRY DATE: 01.MAY.2027. 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 THAT THE REPORTED DEVICES WERE USED IN SURGERY ON THE FEMORAL TROCHANTER ON (B)(6) 2017. IT WAS REPORTED THAT THE BLADE WAS INTERFERING WITH THE NAIL WHEN THE BLADE WAS INSERTED DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE TIP OF THE BLADE WAS BROKEN DUE TO THIS INTERFERENCE. NO BROKEN PIECE WAS LEFT IN THE PATIENT. ACCORDING TO THE SURGEON¿S OPINION, THE INTERFERENCE WAS CAUSED BY THE LOOSENESS OF THE DEVICES. NO DELAY IN SURGERY WAS REPORTED. NO PATIENT HARM WAS REPORTED, NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS OKAY. CONCOMITANT DEVICES REPORTED: PFNA-II Ø10 XS 125° L170 TAN (PART # 472.101S, LOT # L150160, QUANTITY 1), BOLT Ø4.9 SELF-TAP L32 TAV GREEN (PART # 459.320VS, LOT # 5941336, QUANTITY 1), PFNA-II END CAP (PART # 473.170S, LOT #L424146, QUANTITY 1). THIS REPORT IS FOR ONE (1) PROXIMAL FEMORAL NAIL ANTIROTATION-II (PFNA-II) BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601917 PFNA-II BLADE L95 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH L413305

    Patients

    Seq Age Sex Outcome Treatment
    1