BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL 2.7MM LOCKING SCREW

    MDR report key: 6431246 · Received March 24, 2017

    Report

    Report Number
    0001822565-2017-01744
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    October 17, 2016
    Report Date
    June 4, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK063303
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1820001822565-2016-04337).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEE RETURNED, BUT THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. RETURNED, NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. AS RETURNED, THE SCREW IS SEIZED INTO THE HOLE ON THE RETURNED PLATE. DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. THE SCREW HEAD EXHIBITS TWO CRACKS AND CORROSION IS ON BOTH THE RETURNED SCREW AND THE RETURNED PLATE. ACCORDING TO SCANNING ELECTRON MICROSCOPY ANALYSIS: ENERGY-DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS OF THE BASE MATERIAL OF THE BONE SCREW INDICATED THE ELEMENTS CONSISTENT WITH A STAINLESS STEEL ALLOY. EDS ANALYSIS OF THE BASE MATERIAL OF THE BONE PLATE INDICATED THE ELEMENTS CONSISTENT WITH A STAINLESS STEEL ALLOY. EDS ANALYSIS OF THE ¿BROWN SPECKS¿ INDICATED PRIMARILY THE ELEMENTS C, O, P, CA, MN, AND FE, WITH TRACE AMOUNTS OF NA, S, CL, K, CR, AND CO. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. A TOTAL OF TWO (2) MEDWATCH REPORTS HAVE BEEN FILED REGARDING THIS EVENT; PLEASE ALSO REFERENCE 0001822565-2017-04337.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING REVISION OF A PERIARTICULAR PLATE, SPECKS OF BROWN DEBRIS COULD BE FOUND ON THE UPPER SIDE OF THE DEVICE, AS WELL AS MATERIAL DEBRIS ON THE BOTTOM SIDE OF THE DEVICE, WHICH CAUSED DIFFICULTY WITH REMOVAL. SIGNIFICANT CORROSION WAS ALSO NOTED AROUND THE SCREW-PLATE JUNCTION. INITIAL OPERATIVE NOTES INDICATED THAT THE X-RAYS TAKEN SHOWED GOOD POSITIONING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING REVISION OF A PERIARTICULAR PLATE, SPECKS OF BROWN DEBRIS COULD BE FOUND ON THE UPPER SIDE OF THE DEVICE, AS WELL AS MATERIAL DEBRIS ON THE BOTTOM SIDE OF THE DEVICE, WHICH CAUSED DIFFICULTY WITH REMOVAL. SIGNIFICANT CORROSION WAS ALSO NOTED AROUND THE SCREW-PLATE JUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215249 UNIVERSAL 2.7MM LOCKING SCREW PLATE, FIXATION HRS ZIMMER, INC. N/A 63034836

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R