BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3973781 · Received August 1, 2014

    Report

    Report Number
    2520274-2014-12982
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DATE OF BIRTH REPORTED ONLY AS 1962. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED BROKEN IN FOUR PIECES. THE REAMER HEADS WAS CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE BROKEN SURFACES SHOW NO IRREGULARITIES, WHICH INDICATE MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL. THE CUTTING EDGES SHOW A LOT OF WEAR MARKS AND THEY ARE STRONGLY WORN. SOME SMALL PARTS ARE BROKEN OFF. IT IS LIKELY THAT EITHER THE REAMER HEAD CAME IN CONTACT WITH A METALLIC PART OR SIMPLY TOO MUCH MECHANICAL FORCE, WELL BEYOND ITS CALCULATED DESIGN WAS APPLIED DURING THE SURGERY WHICH CAUSED THESE BREAKAGES. PLEASE NOTE; BLUNT REAMER REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE RECOMMEND THAT BLUNT OR DAMAGED INSTRUMENTS NEED TO BE EXCHANGED BEFORE SURGERY. NO PRODUCT FAULT COULD BE DETECTED. 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

    THIS REPORT IS AN UNKNOWN REAMER HEAD. PART NUMBER PROVIDED 352.089 BUT NOT ABLE TO BE VERIFIED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HEAD BROKE INTO FOUR PIECES DURING REAMING. THE INDICATION FOR REAMING WAS TIBIA OSTEOMYELITIS AND THEREFORE IMPORTANT THAT ALL METAL WAS REMOVED. THIS PROLONGED THE SURGERY SIGNIFICANTLY, BUT THE EXACT TIME DELAY IS UNKNOWN. THE HEAD WILL BE SENT FOR INVESTIGATION LATER ON. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO HAVE PROLONGED THE SURGERY APPROXIMATELY 15 TO 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450477 8.5MM MEDULLARY REAMER HEAD REAMER HTO SYNTHES SELZACH 26947

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR