BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR-M8

    MDR report key: 6449444 · Received March 31, 2017

    Report

    Report Number
    3005180920-2017-00146
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 31, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 15 MARCH 2017, THE MANUFACTURER OF THE INSTRUMENT PROVIDED A DOCUMENT REVIEW REPORTING AS FOLLOWS: BATCH RELEASED ON DATE: 29 SEPTEMBER 2016. N. OF PIECES RELEASED: (B)(4). ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. WE HAVE RECEIVED OTHER COMPLAINT FOR THIS BATCH. CONCLUSIONS: THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. ON 31 MARCH 2017 THE MEDACTA (B)(4) PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: BOTH ACETABULAR SHELL AND CUP IMPACTOR ARE AVAILABLE: THE TIP OF THREADED PART OF THE CUP IMPACTOR IS BROKEN AND ALSO THE THREADED HOLE OF THE IMPLANT IS SLIGHTLY SCRATCHED. IT IS POSSIBLE TO ASSUME THAT THE INSTRUMENT HAS BEEN "SPOLT" DUE TO THE REPEATED USAGE AND HIGH TORSION FORCE. BATCH REVIEW PERFORMED ON 31 MARCH 2017. LOT 165899: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 DECEMBER 2016. EXPIRATION DATE: 2021-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    UPON IMPACTION, THE CUP BECAME STRIPPED AND THE IMPACTOR BROKE. THE THREADING ON THE IMPACTOR IS NO LONGER INTACT. NO FRAGMENTS FELL INTO THE PATIENT. THERE WAS A SHORT DELAY OF APPROXIMATELY 5 MINUTES. THE SURGEON USED A SECONDARY IMPACTOR AND A NEW SHELL TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INSTRUMENT AND THE IMPLANT ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231793 AMIS CUP IMPACTOR-M8 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 16HA264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other