BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 5684681 · Received May 27, 2016

    Report

    Report Number
    2520274-2016-12892
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 13, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT:: ONE 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS (PART NUMBER: 357.366, LOT NUMBER: 8860042, MFG. DATE: 27MAY2014; PART 1) ONE INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS (PART NUMBERS: 357.411, LOT NUMBER: 4537011, MFG. DATE: 13MAR2003; PART 2) THE PART(S) WERE RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿DURING A SHORT TROCHANTERIC FIXATION NAILING (TFN) PROCEDURE, WHILE ATTEMPTING THE DISTAL CROSS LOCK, THE GUIDE MISSED THE HOLE IN THE NAIL. THE SURGEON ATTEMPTED SEVERAL TIMES AFTER CHECKING THE ANGLE AND MAKING SURE THE INSERTION HANDLE WAS TIGHT, AND WAS ABLE TO FREE HAND THE LOCKING WHICH INCURRED A 45 MINUTE DELAY TO SURGERY¿. THE RETURNED INSTRUMENTS WERE RECONSTRUCTED TOGETHER IN AN ATTEMPT TO RECREATE THE COMPLAINT CONDITION, BUT THE COMPLAINT CONDITION COULD NOT BE RECREATED. ALIGNMENT OF THE AIMING ARM WITH THE INSERTION HANDLE WAS ACHIEVED WHEN ATTEMPTING TO RECREATE THE COMPLAINT CONDITION, BUT DURING THE SUBJECT PROCEDURE OTHER VARIABLES COULD HAVE CONTRIBUTED TO THE DRILL BIT NOT GOING INTO THE NAIL. SINCE ONLY THE AIMING ARM, AND THE INSERTION HANDLE WERE RETURNED, IT IS NOT POSSIBLE TO DETERMINE IF THE OTHER PARTS WHICH INTERACTED WITH BOTH DEVICES DURING THE COMPLAINT CONTRIBUTED TO THE GUIDE MISSING THE HOLE IN THE NAIL. ADDITIONALLY, OTHER FACTORS SUCH AS THE PATIENT¿S CONDITION AND PHYSICAL ATTRIBUTES COULD HAVE IMPACTED THE POSITIONING OF THE INSTRUMENTATION USED TO FACILITATE LOCKING AND CONTRIBUTED TO THE COMPLAINT CONDITION. DUE TO THE TIGHT TOLERANCES AND DESIGN, THE CONSTRUCT(S) IS SUSCEPTIBLE TO LATERAL FORCES DURING THE SURGERY THAT ARE UNABLE TO BE REPLICATED IN CUSTOMER QUALITY. IT IS LIKELY THAT SOFT TISSUE DISTRACTION FORCES ARE THE CAUSE OF THIS COMPLAINT CONDITION. ALL PARTS RECEIVED WERE IN GOOD CONDITION WITH SOME MINOR WEAR AND TEAR ON THE DEVICES. 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

    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 WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART NUMBER: 357.411, SYNTHES LOT NUMBER: 4537011, RELEASE TO WAREHOUSE DATE: 13-MAR-2003, MFG SITE: BRANDYWINE, MRR # 42568 WAS GENERATED DURING PRODUCTION FOR FEATURES L10, L12, AND L20 BEING OUT OF SPECIFICATION. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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 A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAILING (TFN) PROCEDURE ON (B)(6) 2016. AS THE SURGEON WAS ATTEMPTING THE DISTAL CROSS LOCK, THE GUIDE MISSED THE HOLE IN THE NAIL. AFTER THE ANGLE WAS CHECKED FOR ACCURACY AND THE INSERTION HANDLE WAS CHECKED FOR TIGHTNESS, THE SURGEON MADE SEVERAL ADDITIONAL ATTEMPTS TO INSERT THE NAIL. ULTIMATELY, THE SURGEON WAS ABLE TO FREE-HAND THE LOCKING OF THE NAIL. AS A RESULT OF THE INTRA-OPERATIVE ISSUES, THE PROCEDURE WAS EXTENDED BY FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED HARM TO THE PATIENT. FOLLOWING THE PROCEDURE, THE GUIDE WAS INSPECTED WITH AN ALTERNATE NAIL. THE DEVICES ALIGNED WITHOUT ISSUE. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339375 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4537011

    Patients

    Seq Age Sex Outcome Treatment
    1