BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HR004, S/M ALEXIS ORTHO PROT 5/BX

    MDR report key: 19671309 · Received July 3, 2024

    Report

    Report Number
    2027111-2024-00727
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    October 17, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: THP ANTERIOR DESCRIPTION OF EVENT: THE SURGEON USES 2 TYPES OF WOUND PROTECTORS: 1. [NAME] M. 2. ALEXIS ORTHOPEADIC HR004. BECAUSE OF BACKORDER PROBLEMS OF COMPETITOR PRODUCT THE SURGEON STARTED TO USE THE ALEXIS ORTHO. HE PREFERS HOWEVER THE [NAME] BECAUSE OF THE FOLLOWING REASONS: 1. THE [NAME] IS A LOT CHAEPER / PRICE 2. THE INNER RING IS LARGER, WHICH HE PREFERS. THE ALEXIS INNER RING POPS OUT MORE OFTEN. 3. THE SHEET TEARS AS FREQUENT AS THE ALEXIS ORTHO DURING THE CASE I ATTENDED HE USED THE HR004. THE MALE HE OPERATED ON WAS RELATIVELY YOUNG, THEREFORE MORE MUSCLE TENSION AND A SMALLER SPACE TO OPERATE. WHEN USING THE BROACH IN THE FEMUR, THE ALEXIS SHEET GOT DAMAGED. ALSO WHEN FITTING THE CUP IN THE ACETABULUM. IN THE END A SMALL TEAR/ HOLE WAS SEEN. THE SURGEON MENTIONED THE TEARS ALWAYS HAPPEN ON THE SAME PLACES IN THE SHEET. DOESN'T MATTER WHICH BRAND HE USES. OTHER FEEDBACK: DIFFICULT TO ROLL THE OUTER RIDGID RING ALONE. I SUGGESTED TO TRY THE FLEXIBLE RING. ALSO HE'S GOING TO TRY IT FOR THE POSTEROLATERAL APPROACHES. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL 28JUN26: WHEN THE SURGEON USED THE BROACH IN THE FEMUR. DUE TO THE POSITION OF THE SHAFT OF THE BROACH IT EASILY CATCHES THE SHEET OF THE ALEXIS. DUE TO FORCES APPLIED THE SHEET TEARS. JUST LEFT THE HOLE IN THE SHEET AND PROGRESSED WITH THE PROCEDURE. INTERVENTION: JUST LEFT THE HOLE IN THE SHEET AND PROGRESSED WITH THE PROCEDURE. PATIENT STATUS: PATIENT IS OK.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: THP ANTERIOR. DESCRIPTION OF EVENT: THE SURGEON USES 2 TYPES OF WOUND PROTECTORS: 1. [NAME] M. 2. ALEXIS ORTHOPEADIC HR004. DURING THE CASE I ATTENDED HE USED THE HR004. THE MALE HE OPERATED ON WAS RELATIVELY YOUNG, THEREFORE MORE MUSCLE TENSION AND A SMALLER SPACE TO OPERATE. WHEN USING THE BROACH IN THE FEMUR, THE ALEXIS SHEET GOT DAMAGED. ALSO WHEN FITTING THE CUP IN THE ACETABULUM. IN THE END A SMALL TEAR/ HOLE WAS SEEN. THE SURGEON MENTIONED THE TEARS ALWAYS HAPPEN ON THE SAME PLACES IN THE SHEET. DOESN'T MATTER WHICH BRAND HE USES. OTHER FEEDBACK: DIFFICULT TO ROLL THE OUTER RIDGID RING ALONE. I SUGGESTED TO TRY THE FLEXIBLE RING. ALSO HE'S GOING TO TRY IT FOR THE POSTEROLATERAL APPROACHES. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL 28JUN26: WHEN THE SURGEON USED THE BROACH IN THE FEMUR. DUE TO THE POSITION OF THE SHAFT OF THE BROACH IT EASILY CATCHES THE SHEET OF THE ALEXIS. DUE TO FORCES APPLIED THE SHEET TEARS. JUST LEFT THE HOLE IN THE SHEET AND PROGRESSED WITH THE PROCEDURE. INTERVENTION: JUST LEFT THE HOLE IN THE SHEET AND PROGRESSED WITH THE PROCEDURE. PATIENT STATUS: PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901622 HR004, S/M ALEXIS ORTHO PROT 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES HR004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BROACH.| HOHMANN RETRACTORS.| PULSE LAVAGE.| REAMER.| SNIPPED (CABLE RETRACTOR HOLDERS).