BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2017-10026

    MDR report key: 6268835 · Received January 20, 2017

    Report

    Report Number
    1221934-2017-10026
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 27, 2016
    Report Date
    December 27, 2016
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND VISUALLY INSPECTED. VISUAL OBSERVATIONS REVEALED THAT THE DISTAL TIP WAS BROKEN OFF THE DEVICE, CONFIRMING THE COMPLAINT. HISTORICALLY, THIS TYPE OF FAILURE IS ASSOCIATED WITH EXCESSIVE FORCE APPLIED DURING APPLICATION. A DHR HAS BEEN AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS SERIAL NUMBER THAT WAS RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE SALES REP REPORTED VIA PHONE THAT DURING AN ACL PROCEDURE AN INCH AND A HALF LONG PIECE OF THE TIP OF THE CUSTOMER'S STRYKER OBTURATOR BROKE OFF INTO THE PATIENT. ALL PIECES AND DEBRIS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO PATIENT CONSEQUENCES BUT A 15-20 MINUTE DELAY WAS REPORTED. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE SALES REP REPORTED VIA PHONE THAT DURING AN ACL PROCEDURE AN INCH AND A HALF LONG PIECE OF THE TIP OF THE CUSTOMER'S STRYKER OBTURATOR BROKE OFF INTO THE PATIENT. ALL PIECES AND DEBRIS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO PATIENT CONSEQUENCES BUT A 15-20 MINUTE DELAY WAS REPORTED. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Patients

    Seq Age Sex Outcome Treatment
    1