BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4574914 · Received March 6, 2015

    Report

    Report Number
    2520274-2015-11481
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Report Date
    February 8, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.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. DEVICE INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT WAS PROVIDED. 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: TWO 130 DEGREE AIMING ARMS (357.366 LOTS 3380178 MFG 4/2010, 5032824 MFG 7/2005) WERE RECEIVED WITH WEAR PRESENT ON THE LOCKING SLIDE PLATE AND SURROUNDING AREA WHICH IS CONSISTENT WITH ACCEPTING, HOLDING AND REMOVAL OF A BLADE GUIDE SLEEVE. WHILE EXCESSIVE PLAY WAS SEEN IN THE ASSEMBLY, THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED WITH KNOWN GOOD COMPONENTS; AS SUCH THE COMPLAINT IS UNCONFIRMED. THE COMPLAINT CONDITION OF WILL NOT HOLD WAS UNABLE TO BE CONFIRMED USING KNOWN GOOD MATING COMPONENTS. AS SUCH THE COMPLAINT IS UNCONFIRMED. THE AWARENESS DATE OF THE COMPLAINT IS (B)(6) 2015 NOT (B)(6) 2015 AS REPORTED IN INITIAL COMPLAINT. 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 WITH TWO 130 DEGREE AIMING ARMS FOR TROCHANTERIC FIXATION NAILS WOULD NOT HOLD THE BUTTRESS COMPRESSION NUT. THE INSTRUMENT WOULD POP OUT THE BUTTRESS COMPRESSION NUT ON THE TRIPLE SLEEVES EVERY TIME WHEN YOU PUT TENSION ON IT TO BUTTRESS OR ENGAGE COMPRESSION. IT ONLY DOES IT UNDER TENSION EITHER WAY. THERE IS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157756 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES HAGENDORF 3380178

    Patients

    Seq Age Sex Outcome Treatment
    1