BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX

    MDR report key: 4210422 · Received October 29, 2014

    Report

    Report Number
    3003875359-2014-10346
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: SYNTHES (B)(4) MANUFACTURED THE AIMING ARM FOR CANNULATED TIBIAL NAILS, PART 03.010.052, AND LOT 5015859 (SUPPLIER LOT 1355562). INITIALLY, THE PART CONFORMED TO THE SYNTHES FINAL INSPECTION SHEETS. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE AIMING ARM, FOR TITANIUM CANNULATED TIBIAL NAILS-EX IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM CANNULATED TIBIAL NAILS SYSTEM. THE RETURNED AIMING ARM, FOR TITANIUM CANNULATED TIBIAL NAILS-EX IS IN FAIRLY POOR CONDITION WITH SIGNIFICANT DISCOLORATION AND SIGNS OF WEAR. THE DEVICE WAS RETURNED AND REPORTED THAT THE DRILL SLEEVE DOES NOT SLIDE INTO THE AIMING ARM¿S GUIDING HOLES. THE COMPLAINT DESCRIPTION DESCRIBES THE AIMING ARM AS ¿BADLY DAMAGED DUE TO REPEATED STRIKES WITH A HAMMER.¿ THIS CONDITION IS CONFIRMED TEST SAMPLE WOULD NOT SLIDE INTO THE A/P HOLE. IT IS LIKELY THAT THE DEVICE WAS HAMMERED ON SIGNIFICANTLY CAUSING THE SHAPE OF THE HOLE TO BECOME BENT AND DISTORTED PREVENTING THE PROTECTION SLEEVE FROM BEING USED WITH THE A/P HOLE. IT IS LIKELY THAT EXCESSIVE HAMMERING ON THE DEVICE LED TO THIS CONFIRMED COMPLAINT; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. 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 AS FOLLOWS: IT WAS REPORTED THE DRILL SLEEVE DOES NOT SLIDE INTO THE GUIDING HOLES. INSTRUMENT APPEARS TO BE BADLY DAMAGED LIKELY DUE TO REPEATED STRIKES WITH A HAMMER. THERE WAS NO INJURY OR HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED, IT IS UNKNOWN IF THERE WAS ANY TYPE OF SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691682 AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX GUIDE FZX SYNTHES HAGENDORF 5015859/1355562

    Patients

    Seq Age Sex Outcome Treatment
    1