BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 4240908 · Received November 10, 2014

    Report

    Report Number
    2520274-2014-14582
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PATIENT HAD A MIDSHAFT TIBIA/FIBULA FRACTURE FROM AN INJURY IN A SOCCER GAME. THE PATIENT CAME TO THE OPERATING ROOM TO HAVE A TIBIA NAIL IMPLANTED. THE PATIENT'S CANAL WAS VERY SMALL AND DURING THE REAMING WITH THE INITIAL 8.5MM REAMING HEAD THE DOCTOR HAD TROUBLE PASSING THE REAMER PAST THE MIDSHAFT PORTION OF THE BONE. AFTER TRYING 15 MINUTES, HE THEN BACKED THE REAMER OUT TO TRY AND CLEAN THE REAMER HEAD AND TOOK AN X-RAY AND NOTICED A PIECE OF THE REAMER HEAD HAD BROKEN OFF IN THE TIBIA. THE PART NUMBER WAS 352.085 AND THE LOT NUMBER WAS 2162802 AND THE PIECE THAT BROKE OFF WAS NOT ON THE TIP OF THE REAMER BUT ON THE OPPOSITE END THAT SLIDES ON TO THE FLEXIBLE SHAFT. AFTER ANOTHER 15 MINUTES THE DOCTOR WAS ABLE TO RETRIEVE A LARGE PIECE OF THE BROKEN OFF PART THAT WAS IN THE PATIENT TIBIA. THE DOCTOR PROCEEDED TO REAM WITH ANOTHER REAMER SET FROM DEPUY THAT THE HOSPITAL HAD IN HOUSE THAT HAS AN 8.0 REAMER AND THEN USED THE 8.5MM REAMER AS WELL FROM DEPUY SET AND THOSE WORKED. FOLLOWING THIS THE SURGEON WENT BACK TO THE SYNTHES 9.0MM REAMER HEAD AND CONTINUED WITHOUT ANY PROBLEMS REAMING TO THE DESIRED NUMBER BEFORE PUTTING IN A TIBIAL NAIL AND FINISHING THE CASE OFF WITH NO ADDITIONAL PROBLEMS. PATIENT OUTCOME WAS SAFE BUT THIS DID CAUSE A DELAY IN THE SURGERY DUE TO THE PATIENT¿S SMALL CANAL SIZE AND THE 8.5MM REAMER STRUGGLING TO PASS DOWN AND THE PIECE BREAKING OFF IN THE CANAL. THE BROKEN PIECE AND THE REAMER HEAD ARE IN POSSESSION OF THE HOSPITAL AND WILL NOT BE RETURNED TO SYNTHES AT THIS TIME. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722354 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR