BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAL PRO STIRRUPS

    MDR report key: 2915813 · Received January 11, 2013

    Report

    Report Number
    1221538-2013-00002
    Event Type
    Other
    Date Received
    January 11, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ALLEN MEDICAL
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO INJURIES OR IMPACTS TO THE CASE REPORTED. A REVIEW OF OUR RECORDS INDICATED THE USER STAFF HAD SENT THE UNIT IN FOR REPAIR ON (B)(6) 2012. THE UNIT WAS INSPECTED BY ENGINEERING AND IT WAS IMMEDIATELY NOTED THAT BOTH OF THE PINS IN THE STIRRUP BLADE (USED TO ATTACH THIS BLADE TO THE MOUNT OF THE STIRRUP) HAD VISIBLY BACKED OUT OF POSITION. WHEN THE STIRRUP WAS SETUP FOR EVAL, IT WAS NOTED THAT THE LEG HOLDER WOULD NOT HOLD POSITION - VERIFYING THE USER'S REPORT THAT THE PRODUCT COULD NOT BE USED. THE ROOT CAUSE OF THIS CONDITION IS COMPONENT WEAR AND HANDLING. THE ROOT CAUSE OF THE PT-INVOLVED INCIDENT WAS THE USER STAFF'S FAILURE TO DISCONTINUE USE OF THE PRODUCT AFTER IT EXHIBITED IT WAS UNSTABLE. THE DISLOCATED PINS AT THE BASE OF THE UNIT ARE LOCATED IMMEDIATELY IN FRONT OF THE INDIVIDUAL SETTING UP THE PRODUCT PRIOR TO USE THEREFORE THE PIN CONDITION WAS HIGH VISIBLE. THE RISK OF INJURY FOR SUCH A CONDITION HAS DETERMINED TO BE MINOR DUE TO THE HIGH DETECTABILITY OF THESE CONDITIONS. THE IFU FOR THE PRODUCT STATES THAT USE OF THE PRODUCT SHOULD BE DISCONTINUED SHOULD ANY VISIBLE DAMAGE BE NOTED AND/OR IF THE STIRRUP APPEARS UNSTABLE. THIS PRODUCT EXHIBITED BOTH CONDITIONS. THE IFU FOR THE PRODUCT STATES THAT USE OF THE PRODUCT SHOULD BE DISCONTINUED SHOULD ANY VISIBLE DAMAGE BE NOTED AND/OR IF THE STIRRUP APPEARS UNSTABLE. THIS PRODUCT EXHIBITED BOTH CONDITIONS BEFORE FAILURE. A REVIEW OF 10 YRS OF COMPLAINTS ON FILE DEMONSTRATED THAT THERE HAVE BEEN NO INJURIES ASSOCIATED WITH THIS CONDITION AMONGST ANY OF ALLEN MEDICAL'S PRODUCT LINES. THE RESULTS OF THIS INVESTIGATION WERE FORWARDED TO THE RPTR. WE ARE WORKING WITH THEIR STAFF.

    Description of Event or Problem · 1

    ON (B)(6) 2012 ALLEN MEDICAL REC'D A COPY OF VOLUNTARY MEDWATCH (B)(4) FORWARDED TO US BY THE DEPARTMENT OF HEALTH & HUMAN SERVICES. THE REPORT RESULTED FROM A PT INVOLVED INCIDENT W/O INJURY. ACCORDING TO THE REPORT, THE STAFF WAS USING A PAL PRO STIRRUP IN A CASE WHEN A PT'S LEG "FELL." NO INJURY OR SIGNIFICANT IMPACT TO THE CASE'S OUTCOME RESULTED. THE RPTR ADDED THAT THE DEVICE "BROKE" (EG, COULDN'T GET IT TO WORK OR STOPPED WORKING.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17910 PAL PRO STIRRUPS PAL PROS, LEGHOLDERS, STIRRUPS FWZ ALLEN MEDICAL A-10052-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1