BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 6804893 · Received August 18, 2017

    Report

    Report Number
    2530088-2017-10252
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 23, 2017
    Report Date
    July 25, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    UDI-DI
    10886982196347
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW FOR PART: #357.411, SYNTHES LOT #4544026. (B)(4) WAS GENERATED ON PART 357.411, LOT 4544026. IT WAS REPORTED THAT THE INSTRUMENT THREAD DOES NOT ACCEPT ¿GO¿ GAGE. (B)(4). THE RELEVANCE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS(S) SHOWED THAT THERE MAY BE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: SEP 12, 2003. SUPPLIER: (B)(4). 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

    CUSTOMER QUALITY COMPLETED AN INVESTIGATION OF THE RETURNED DEVICES. THE FOLLOWING DEVICES WERE RECEIVED 357.411, LOT 4544026 AND 357.366, LOT 5223477 WITH THE FOLLOWING COMPLAINT DESCRIPTION,"IT WAS REPORTED THAT DURING A TFN (TROCHANTERIC FIXATION NAIL) SURGERY, THE 130 DEGREE AIMING ARM AND THE INSERTION HANDLE DID NOT LINE UP PROPERLY WHEN INSERTING THE DISTAL LOCKING SCREW. THERE ARE TWO DEVICES INVOLVED IN THIS COMPLAINT. A DEVICE HISTORY REVIEW (DHR), DEVICE INSPECTION, AND FUNCTIONAL TEST REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS UNCONFIRMED. CLINICALLY, ALIGNMENT OF THE LOCKING SCREW WAS ACCOMPLISHED WHEN THE USER RE-TIGHTENED THE HANDLE AND AIMING ARM AND DRIVE CAP. FUNCTIONAL REVIEW: REPLICATION CANNOT BE PERFORMED DUE TO NOT HAVING FULL DETAILS ABOUT THE CASE AND NOT HAVING ALL MATING PARTS. UPON INSPECTION, THE AIMING ARM FASTENED TO THE INSERTION HANDLE AS INDICATED. THE COMPLAINT IS UNCONFIRMED. CLINICALLY, ALIGNMENT OF THE LOCKING SCREW WAS ACCOMPLISHED WHEN THE USER RE-TIGHTENED THE HANDLE AND AIMING ARM AND DRIVE CAP. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THIS INVESTIGATION. THE 357.411, LOT 4544026, INSERTION HANDLE AND 357.366, LOT 5223477, AIMING ARM IS USED IN CONJUNCTION WITH EACH OTHER ALONG WITH THE TROCANTERIC NAILS FOR BLADE ALIGNMENT, PER TFN ADVANCED PROXIMAL FELMORAL NAILING SYSTEM, DSUS/TRM/0614/0109(5) 7/16 TECHNIQUE GUIDE. VISUAL INSPECTION: UPON INSPECTION, THE AIMING ARM FASTENED TO THE INSERTION HANDLE AS INDICATED. THE DEVICES SHOWED WEAR OFTEN ASSOCIATED WITH REPEAT USE AFTER 11 YEARS OF FIELD USE. THE COMPLAINT IS UNCONFIRMED. CLINICALLY, ALIGNMENT OF THE LOCKING SCREW WAS ACCOMPLISHED WHEN THE USER RE-TIGHTENED THE HANDLE AND AIMING ARM AND DRIVE CAP. DHR REVIEW FOR PART: #357.411 -SYNTHES LOT #4544026 MRR #43812 WAS GENERATED ON PART 357.411 LOT 4544026. REVIEW OF THIS MRR UPON RECEIPT OF THE DEVICES DETERMINED THAT IT IS NOT RELATED TO THE COMPLAINT CONDITION AS IT CONCERNS THE ATTACHMENT WITH THE AIMING ARM WHICH WAS FOUND TO FASTEN TO THE INSERTION HANDLE AS INDICATED DURING THE INVESTIGATION. DRAWING REVIEW: DRAWINGS WERE REVIEWED AND THE HOLE PATTERNS VERIFIED THE PARTS ARE ACCEPTABLE AND MEET PRINT. DCRM REVIEW: A DCRM REVIEW AND/OR OCCURRENCE RATE CALCULATION MUST BE PERFORMED FOR ALL COMPLAINT PARTS WHICH RESULTED IN A CLASSIFICATION OF SERIOUS INJURY THAT WERE NOT GENERATED FROM A LITERATURE ARTICLE. THEREFORE NO DCRM CALCULATION WILL BE PERFORMED FOR THIS COMPLAINT. NO DEFINITE ROOT CAUSE CAN BE DETERMINED WHY THE ALIGNMENT TO THE LOCKING SCREW OF THE INSERTION HANDLE AND AIMING GUIDE DID NOT TAKE PLACE. UPON INSPECTION, THE AIMING ARM FASTENED TO THE INSERTION HANDLE AS INDICATED. THE COMPLAINT IS UNCONFIRMED. 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 THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) SURGERY ON (B)(6) 2017, THE 130 DEGREE AIMING ARM AND THE INSERTION HANDLE DID NOT LINE UP PROPERLY WHEN INSERTING THE DISTAL LOCKING SCREW. THE NAIL AND THE HELICAL BLADE WERE BOTH ALREADY IN PLACE. THE SURGEON ADJUSTED AND TIGHTENED THE AIMING ARM, HANDLE AND THE DRIVING CAP, AND WAS THEN ABLE TO USE THE INSTRUMENTS TO IMPLANT THE DISTAL SCREW AS INTENDED. THERE WERE NO FRAGMENTS GENERATED, NO SURGICAL DELAY, AND NO ADDITIONAL MEDICAL INTERVENTION. THE SURGERY WAS COMPLETED, AND THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: TFN NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); HELICAL BLADE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); DISTAL LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); DRIVING CAP (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INSERTION HANDLE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583829 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4544026 10886982196347

    Patients

    Seq Age Sex Outcome Treatment
    1