BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP KIT

    MDR report key: 6126190 · Received November 23, 2016

    Report

    Report Number
    0001526350-2016-00134
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 25, 2016
    Report Date
    July 17, 2017
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES. ALTHOUGH, PRODUCT EXAMINATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED FOR THIS COMPLAINT, THE COMPLAINT IS CONFIRMED BASED ON THE ACCOUNT ADMITTING THAT THE NURSE CUT THE WIRE TO THE BATTERY PACK WITH SCISSORS. USING VIEW 3.2 FROM THE ETQ RELIANCE SYSTEM, FROM OCTOBER 26, 2015 TO OCTOBER 25, 2016, THERE WERE 16 CLOSED COMPLAINTS THAT USED THE SAME RISK MANAGEMENT FILE AS PART OF THEIR RESPECTIVE RISK ASSESSMENT. THE SCOPE OF THIS SEARCH INCLUDES ALL PART NUMBERS CONTAINED WITHIN THE SAME RISK MANAGEMENT FILE. IT IS KNOWN THAT CUTTING THE WIRE CAN CREATE A SHORT CIRCUIT WITHIN THE BATTERY PACK. THE PULSAVAC IFU STATES, ¿DO NOT CUT THE BATTERY PACK CABLE. CUTTING THROUGH THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE AND/OR PERSONAL INJURY.¿ A CORRECTIVE ACTION IS IN PROCESS TO DIRECTLY ADDRESS CUSTOMERS CUTTING THE BATTERY CABLE. THE ROOT CAUSE FOR THIS COMPLAINT IS THAT THE CUSTOMER CUT THE WIRE, CREATING A SHORT CIRCUIT WITHIN THE BATTERY PACK. THIS SHORT CIRCUIT CAUSED THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE BATTERY PACK EXHIBITED EXPULSION DURING SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON NOVEMBER 2, 2016 STATED THAT THE PRODUCT FAILURE OCCURRED AFTER SURGERY DURING CLEAN UP (AFTER THE COMPLETION OF SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776791 HIP KIT LAVAGE, JET FQH ZIMMER SURGICAL, INC. N/A 63331509

    Patients

    Seq Age Sex Outcome Treatment
    1