BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 5321637 · Received December 22, 2015

    Report

    Report Number
    3004976965-2015-00039
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    HWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED TO GREATBATCH FOR EVALUATION AND THE REPORTED EVENT CANNOT BE CONFIRMED. A PROCESS REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. THE INITIAL INVESTIGATION WAS NOT COMPLETED BY THE DISTRIBUTOR ((B)(6)) AND DID NOT CONFIRM THE MALFUNCTION AS REPORTED. NO FURTHER INVESTIGATION IS REQUIRED. (B)(6). DEVICE NOT RETURNED TO DISTRIBUTOR.

    Additional Manufacturer Narrative · 1

    GREATBATCH MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTOR BROKE DURING SURGERY. IT WAS NOTICED DURING X-RAY IN SURGERY THERE WAS A SMALL PIECE REMAINING IN THE PATIENT. THE SURGEON REMOVED THE CUP, REMOVED THE SMALL PIECE OF METAL AND INSERTED A NEW CUP, DELAYING SURGERY 15 MINUTES WITH NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843833 OFFSET CUP IMPACTOR OFFSET CUP IMPACTOR HWA GREATBATCH MEDICAL OR71368569 15AM04717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other