BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 6062348 · Received October 27, 2016

    Report

    Report Number
    9612488-2016-10432
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ESTABLISHMENT NAME, ADDRESS, PHONE NUMBER: (B)(6). 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

    A PRODUCT INVESTIGATION WAS COMPLETED: ALL FOUR HELIX BLADES ARE HEAVILY DAMAGED AT THEIR RUN-INS. THE FLANKS OF THE BODY SLEEVE SHOW ABRADED COLOR STRIATIONS. BESIDE THE DESCRIBED DAMAGE THE BLADE IS FULLY FUNCTIONAL AS IT PASSED THE PERFORMED FUNCTIONAL TEST. THE DEVICE PASSED THE BLADE BORE OF A TEST PFNA-II NAIL AND COULD BE LOCKED AND UNLOCKED AS FORESEEN. THE DAMAGE ON ALL FOUR HELIX BLADES POINTS TO THE FACT THAT THE BLADE HIT THE SIDE WALLS OF THE BORE IN THE PFNA II NAIL. THE DAMAGE IS CONSISTENT WITH MISALIGNMENT AND APPLICATION OF HIGH EXPENDITURE OF ENERGY. THE REVIEW OF THE MANUFACTURING DOCUMENTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT BUT WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES OF THE INVESTIGATED BLADE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODE IS HWC. (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. (B)(6). THE 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER L021213. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: JUN 17, 2016. EXPIRATION DATE: JUN 1, 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THE SURGERY WAS PROLONGED ABOUT FIVE TO TEN MINUTES. UPDATED CONCOMITANT PART INFORMATION: PFNA-II Ø 11.0MM, SMALL (PART 472.116S, LOT NUMBER 9930313, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROXIMAL FEMUR NAIL ANTIROTATION II (PFNA-II) FIXATION PROCEDURE ON (B)(6) 2016, THE PFNA-II BLADE COULD NOT BE INSERTED INTO THE PFNA NAIL HOLE. IT WAS REPORTED THAT THE AFTER FIXING THE NAIL ONTO THE INSERTION GUIDE AND AIMING ARM, ALIGNMENT WAS CHECKED. THE REAMER WAS ABLE TO PASS THROUGH NAIL HOLE SMOOTHLY. THEN NAIL WAS INSERTED INTO THE FEMUR AND THE SURGEON INSERTED GUIDE WIRE FOR THE BLADE AND MEASURED AND REAMED. WHILE REMOVING THE REAMER, THE GUIDE WIRE CAME OUT TOGETHER WITH THE REAMER. THE SURGEON PUT THE WIRE BACK THEN TRIED INSERTING THE PFNA-II BLADE. THE BLADE DID NOT GO IN AND X-RAY SHOWED THE BLADE MIGHT BE HITTING THE NAIL. THE BLADE WAS STOPPING OUTSIDE THE NAIL HOLE. THE SURGEON TRIED TO REMOVE THE GUIDE WIRE AND PASS THE REAMER THROUGH AGAIN. THE REAMER WAS ABLE TO PASS THROUGH AND WENT INTO THE FEMUR HEAD. THE SURGEON AGAIN TRIED TO INSERT THE BLADE BUT THE BLADE AGAIN WOULD NOT GO IN. THE X-RAY SHOWED THE GUIDE WIRE DID PASS THROUGH THE HOLE IN THE NAIL AND THE WIRE SEEMED STRAIGHT. A NEW L90 PFNA-II BLADE WAS OPENED AND WAS ABLE TO BE SUCCESSFULLY INSERTED. THE PATIENT'S POSTOPERATIVE CONDITION WAS REPORTED AS STABLE. CONCOMITANT DEVICES: ONE, UNKNOWN AIMING ARM; ONE, UNKNOWN PFNA-II NAIL; ONE, PART NUMBER 356.830 GUIDE WIRE 3.2MM FOR PFNA BLADE, LOT NUMBER UNKNOWN; ONE, PART NUMBER 356.821, REAMER Ø 11.0MM, F/PFNA BLADE, LOT NUMBER UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710825 PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH L021213

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE, 356.821, REAMER Ø 11.0MM, F/PFNA BLADE| ONE, 356.830 GUIDE WIRE 3.2MM FOR PFNA BLADE| ONE, UNKNOWN AIMING ARM| ONE, UNKNOWN PFNA-II NAIL