BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP-KERRISON PUNCH

    MDR report key: 3855625 · Received April 14, 2014

    Report

    Report Number
    8010343-2014-00001
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 11, 2014
    Manufacturer
    GEBRUEDER ZEPF MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    LRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER HAS COMPLAINED ABOUT TAP KERRISON PUNCHES. DURING AN OPERATION, THE PUSH-BUTTON ON AN INSTRUMENT SPRANG OFF AND FELL INTO THE PT. THE SPRING AND THE PUSH-BUTTON CAP FELL INTO THE PT. THESE WERE ABLE TO BE REMOVED WITHOUT ANY PROBLEMS. THE HOSPITAL HAS SIMPLY COMPLAINED ABOUT THE INSTRUMENTS AND HAS NOT INSTIGATED ANY FURTHER STEPS. AS A RESULT OF THE PUSH-BUTTON RELEASING, A RISK OF ENDANGERING THE PT RESULTED. AS A RESULT, THE COMPLAINT IS CLASSIFIED AS A NOTIFIABLE EVENT AND THE RISK ASSESSED AS HIGH. A FIELD SAFETY CORRECTIVE ACTION IS BEING PREPARED AND SUBMITTED TO THE AFFECTED MARKETS AND AUTHORITIES. INFO TO ALL CUSTOMERS WHO ORDER THESE ARTICLES. THE CUSTOMERS ARE REQUESTED TO CHECK ALL INSTRUMENTS RECEIVED WITH PUSH-BUTTONS. IN ADDITION, THE AFFECTED CUSTOMERS WILL RECEIVED EXACT INSTRUCTIONS ON HOW TO CARRY OUT THIS CHECK. THIS MUST BE CARRIED OUT WITHIN 3 MONTHS. A CONFIRMATION OF THE PLANNED CHECK WILL BE SENT TO THE CUSTOMER, WHO SHOULD CONFIRM WITHIN 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228186 TAP-KERRISON PUNCH LAMINECTOMY PUNCH LRY GEBRUEDER ZEPF MEDIZINTECHNIK GMBH & CO. KG 13K359PH

    Patients

    Seq Age Sex Outcome Treatment
    1