BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT BROACH EXTRACTOR

    MDR report key: 6090516 · Received November 9, 2016

    Report

    Report Number
    1818910-2016-31191
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT; THE TIP BROKE OFF. THE ROOT CAUSE IS ATTRIBUTED TO WEAR OUT. THE DATE CODE AB1104 INDICATES THE INSTRUMENT WAS MANUFACTURED IN NOVEMBER OF 2004 AND IS OVER 12 YEARS OLD. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY A TREND FOR THIS PRODUCT CODE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    WHILE EXTRACTING TO SUMMIT BROACH, THE TIP OF THE EXTRACTOR BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740082 SUMMIT BROACH EXTRACTOR HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. 1818910 AB1104

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR