BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX

    MDR report key: 5028360 · Received August 25, 2015

    Report

    Report Number
    2520274-2015-15479
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT WAS REPORTED AS (B)(6). PATIENT INITIALS ARE (B)(6). ALTERNATE PATIENT IDENTIFIER IS (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. 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 SERVICE 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: PART NO: 03.010.052, LOT NO: 9241100: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 05JANUARY2015. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 03.010.052, AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX, LOT NUMBER 9241100). THE 03.010.052 AIMING ARM IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM CANNULATED TIBIAL NAILS SYSTEM PER THE TECHNIQUE GUIDE. THE DEVICE WAS RETURNED AND REPORTED TO HAVE CONTRIBUTED TO A DRILL BIT NOT ALIGNING PROPERLY WITH THE PROXIMAL LOCKING HOLES OF THE TIBIAL NAIL. THIS CONDITION IS UNCONFIRMED; THE DEVICE WAS EXAMINED, MEETS SPECIFICATIONS, AND APPEARS TO BE IN NEAR NEW CONDITION. THE CONDITION OF THE DEVICE COUPLED WITH ALMOST A YEAR OF USE WITHOUT COMPLAINT INDICATES THAT THE AIMING ARM IS NOT THE ROOT CAUSE FOR THE MISALIGNMENT DURING SURGERY. IT IS LIKELY THAT THE AIMING DEVICES WERE NOT FASTENED TOGETHER PROPERLY, THE AIMING DEVICES HAD PRESSURE EXERTED ON THEM BY SOFT TISSUE, OR ANOTHER OF THE UNRETURNED AIMING DEVICES WAS DEFECTIVE LEADING TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 1/2015 AND IS LESS THAN A YEAR OLD. THE SUBJECT DEVICE DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT CONDITION FOR THIS DEVICE COULD NOT BE REPLICATED AS THE CONCOMITANT DEVICES WERE NOT RETURNED. 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 PROXIMAL AIMING GUIDE DRILL BIT DID NOT MATCH WITH THE HOLES IN THE NAIL DURING A TIBIAL NAIL PROCEDURE. THE AIMING ARM WAS TAKEN OFF AND THE SURGEON "FREE-HANDED THE PROXIMAL HOLES�O PUT THE PROXIMAL SCREWS IN PLACE. THERE WAS A REPORTED THIRTY (30) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED; THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563010 AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX GUIDE FZX SYNTHES HAGENDORF 9241100

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention