BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 SELF-TAP L14

    MDR report key: 3180590 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03678
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE ADDITIONAL EVALUATION REPORTS THAT THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPER 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 INVESTIGATION SHOWED NO IRREGULARITIES. THE SURFACE OF THE BROKEN SCREW WAS ANALYZED. THE CROSS-SECTIONS ARE HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL. WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN CAUSED THE BREAKAGE OF THE HEAD DURING INSERTION. BASED ON THE FACT THAT THE SCREW GOT MANUFACTURED IN FEBRUARY 2013 WE ARE ABLE TO PROVIDE YOU WITH A CREDIT NOTE IN TERMS OF FAIR DEALING. IN CONCLUSION THIS COMPLAINT DISPOSITION RESULTS ARE INVALID.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS 30 YEARS OLD. THIS PRODUCT WAS USED FOR THE METACARPAL. THE BONE PARTICLE WAS SMALL, SO THE SURGEON SELECTED 1.5 MM. IT WAS BROKEN DURING THE INSERT OF THE SCREW. REPORTEDLY, THE SURGEON STATED THAT THERE MAY HAVE BEEN TOO MUCH POWER. THE BROKEN SHAFTS AND HEADS OF THE SCREW WERE RETRIEVED FROM THE PATIENT. NO PARTS REMAINED IN THE PATIENTS BODY. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280418 CORTSCR Ø1.5 SELF-TAP L14 HWC SYNTHES GMBH 8182272

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR