BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR REAMER HANDLE

    MDR report key: 3970991 · Received July 8, 2014

    Report

    Report Number
    9614497-2014-00185
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER THAT THE DEVICE WILL BE RETURNED TO GREATBATCH MEDICAL FOR EVALUATION. ONCE GREATBATCH MEDICAL RECEIVES THE DEVICE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT NUMBER SHOULD HAVE BEEN MARKED AS FOLLOW-UP 001 BUT IT WAS INADVERTENTLY NUMBERED AS FOLLOW-UP 002 AND SUBMITTED IN ERROR. DATE OF FDA REQUEST AND VIANT MEDICAL AWARENESS OF ERROR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER EMAIL RECEIVED (B)(6) 2014 CUSTOMER REPORTS; DURING AN UNKNOWN PATIENT PROCEDURE, THERE WAS AN ALLEGED FAILURE OF THE REAMER SHAFT AT THE JOINT WITH THE QUICK COUPLING. THIS ALLEGEDLY CAUSED THE INSTRUMENT TO IMPACT THE PHYSICIAN AND ALLEGEDLY CAUSING A DEEP, 8MM LACERATION ABOVE THE LEFT EYEBROW, REQUIRING 2 SUTURES. CUSTOMER STATES THE MALFUNCTION DID NOT CAUSE INJURY TO THE PATIENT UNDERGOING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397861 ACETABULAR REAMER HANDLE REAMER HANDLE HTO GREATBATCH MEDICAL SA 2102-0410 V2009235

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other