BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2014-01037

    MDR report key: 4212899 · Received October 30, 2014

    Report

    Report Number
    2520274-2014-01037
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 24, 2014
    Manufacturer
    SYNTHES ,USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE COMPLAINT PART MDR WAS REASSESSED AND THE STATUS WAS CHANGED FROM NONREPORTABLE AND DEEMED REPORTABLE SI ON OCTOBER 24, 2014 DUE TO THE RATIONALE: AN IMPLANT THAT STICKS MAY NOT OPERATE AS INTENDED, AND MAY RESULT IN AN OPERATIVE DELAY IF NO ALTERNATE INSTRUMENT IS AVAILABLE, AND/OR THE NEED FOR ADDITIONAL MEDICAL/SURGICAL INTERVENTION. 510K #: UNDETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WILL BE RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. FACILITY HAS DISCARDED THE SCREW. PLACEHOLDER.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED ON OCTOBER 9, 2013: THE REMOVAL OF A TIBIAL PLATE AND SCREWS, A SPARE REAMER TUBE AND HOLLOW REAMER GOT STUCK TOGETHER, A HOLLOW REAMER BROKE AT THE TEETH OF THE INSTRUMENT, A CONICAL EXTRACTION SCREW THAT WAS STUCK IN THE EXTRACTION DEVICE, AND AN EXTRACTION BOLT WAS STUCK IN THE EXTRACTION DEVICE. THE TIBIAL PLATE WAS ORIGINALLY IMPLANTED TO TREAT A TIBIAL PLATEAU FRACTURE ON AN UNKNOWN DATE. IT IS UNKNOWN AS TO WHY THE TIBIAL PLATE WAS BEING REMOVED BUT THE SALE CONSULTANT STATED THAT IT MAY BE BECAUSE THE PLATE IS AN OLD PLATE. CONSULTANT REPORTED WHILE THE SURGEON WAS REMOVING THE SCREWS FROM THE PLATE, THE SPARE REAMER TUBE AND HOLLOW REAMER TUBE GOT STUCK TOGETHER AND THE HOLLOW REAMER BROKE AT THE TEETH. IT IS UNKNOWN AS TO WHEN THE SURGEON DISCOVERED THE TWO PIECES GOT STUCK TOGETHER. THE CONICAL EXTRACTION SCREW AND EXTRACTION BOLT BOTH GOT STUCK IN THE EXTRACTION DEVICE DURING REMOVAL OF THE PLATE. ALL THE SCREWS WERE REMOVED FROM THE PATIENT WITH THE EXCEPTION OF TWO. TWO OF THE SCREW HEADS AND PART OF THE SHAFT BROKE OFF AND PART OF THE SHAFTS REMAIN IN THE PATIENTS BONE. THE PART NUMBERS LOT NUMBERS ARE UNKNOWN FOR THE PLATE AND SCREWS THAT WERE REMOVED. NO REPORT OF PATIENT ADVERSE EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT TIME DELAY. PATIENT ID CASE # IS (B)(6). UPDATE - 10/21/2013: ADDITIONAL INFORMATION REPORTED BY CONSULTANT ON 10/18/2013: THE PLATE (A STANDARD PROXIMAL TIBIA LOW BEND PLATE,AN OLDER VERSION) WAS REMOVED BECAUSE THE PATIENT WAS HEALED AND WAS EXPERIENCING SOME IRRITATION SO THE SURGEON REMOVED THE PLATE AND THE SCREWS. IT WAS THE SCREW PRODUCT PART # 309.039 (QTY X3) WHERE THE TWO SCREWS HEADS BROKE OFF AT THE SHAFT AND THESE 2 SHAFTS STILL REMAIN IN THE PATIENTS BONE. NO REVISION TOOK PLACE; NO REPORT OF HARM TO PATIENT. FOR CLARIFICATION: THREE SEPARATE ATTEMPTS WERE MADE TO EXTRACT THE SCREWS/S. A TOTAL OF 3 EXTRACTION BOLTS WERE USED IN THIS CASE. THIS REPORTED EVENT IS FOR ONE UNKNOWN SCREW; THE PART AND LOT NUMBERS ARE UNKNOWN. A TOTAL OF 3 UNKNOWN SCREWS WERE INVOLVED IN THIS INCIDENT. THIS IS REPORT 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695540 HWC SYNTHES ,USA

    Patients

    Seq Age Sex Outcome Treatment
    1