BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3093207 · Received May 4, 2013

    Report

    Report Number
    2520274-2013-02347
    Event Type
    Malfunction
    Date Received
    May 4, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES VERSION AA OF THE SYNREAM DESIGN AND CLINICAL RISK MANAGEMENT DOCUMENT COVERS BREAKAGE OF THE 8.5MM REAMER HEAD IN LINES 20 - 70. THESE RISKS ARE CONTROLLED BY MECHANICAL TESTING AND THE TECHNIQUE GUIDE. SUFFICIENT INFORMATION COULD NOT BE GATHERED TO DETERMINE THE POSSIBLE CAUSE OF THE COMPLAINT. THE DESIGN RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    MANUFACTURE EVAL: THE COMPLETE FRONT PART OF THE REAMER HEAD IS BROKEN OFF; THE REMAINING PART IS STUCK ON THE COUPLING OF THE FLEXIBLE SHAFT. THE BROKEN OFF FRAGMENTS ARE NOT AVAILABLE FOR INVESTIGATION. CONCLUSION BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE REMAINING CUTTING BLADES ARE WORN AND SHOW MARKS AND STRIATIONS OF OFTEN OR FORCIBLE USE. THE MICROSCOPIC ANALYSIS OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. THE DHR SHOWS THAT THE REAMER HEAD MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT: DURING A PROCEDURE, ON (B)(6) 2013, THE HEAD OF AN 8.5MM REAMER BROKE OFF. THE EVENT TOOK PLACE WHEN A TIBIAL INTER-MEDULLARY (IM) ROD WAS BEING IMPLANTED IN THE RIGHT TIBIA. IT WAS REPORTED THERE WAS NO ADVERSE EVENT TO PATIENT, HOWEVER, METAL WILL BE RETAINED IN THE TIBIAL CANAL OF THE PATIENT. THIS REPORT IS FOR A 8.5MM MEDULLARY REAMER HEAD. THIS IS 2 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195814 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES (USA) 22981

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR