BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEXIS O WOUND PROTECTOR-RETRACTOR

    MDR report key: 19669290 · Received July 3, 2024

    Report

    Report Number
    2027111-2024-00724
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    December 5, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117269
    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

    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.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED. 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. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT A SHARP OBJECT OR INSTRUMENT CAME INTO CONTACT WITH THE SHEATH, RESULTING IN A HOLE OR TEAR THAT FURTHER PROPAGATED DUE TO THE STRESS THE SHEATH EXPERIENCES DURING USE. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: THP/ ANTERIOR APPROACH. DESCRIPTION OF EVENT: COMPLAINT 1 OF 2 :(B)(4). - MFR # 2027111-2024-00716. COMPLAINT 2 OF 2 : (B)(4). (NAME REDACTED) STARTED HIS PROCEDURES WITH THE ALEXIS O RIDGID. HE NOTICED THE SHEET TEARED. THEN HE STARTED TO USE THE ALEXIS ORTHO. IN 90% OF CASES HE USES THE ANTERIOR APPOACH AND ALEXIS ORTHO. HE'S USING A RELATIVELY LARGE INCISION. PLACEMENT OF THE SHEET AFTER THE FEMURHEAD IS REMOVED. HE TRIED TO PLACE IT BEFORE BUT HE STATES THAT HE HAS LESS SPACE AND MOVED AWAY FROM THAT. FOR THE OTHER CASES (REVISIONS AND DISPLASIA) HE USES THE LATERAL APPROACH AND NO ALEXIS ORTHO. HE USES A RALATIVELY LARGE INCISION (NO BIKINY INCISION DUE TO MORE WOUND COMPLICATIONS IN RELATION TO STRAIGHT INCISIONS. MORE GRANULATION TUSSUE IN THE GROIN IS SEEN IF BIKINY INCISIONS ARE USED.) ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 28JUN24: 1.IT WAS IN THE MIDDLE OF THE PLASTIC SHEET WERE THE BROACH SOMETIMES CATCHES UP ON THE SHEET (ALEXIS O RIDGID AND ALEXIS ORTHOPEDIC). 2.MALFUNCTION OCCURRED WHEN USING THE BROACH INTO THE FEMUR. 3. DUE TO THE ANGLE OF THE OPERATIONS THE SURFACE OF THE BROACH COMES INTO CONTACT WITH THE SHEET EASILY. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 02JULY24: THE PRODUCT THAT WAS RELATED TO THE TEAR IN THE SHEET WAS THE C8402 INTERVENTION: THE SURGEON FINISHED THE SURGERY WITHOUT COMPLICATIONS. PATIENT STATUS: THE PATIENT IS FINE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: THP/ ANTERIOR APPROACH. DESCRIPTION OF EVENT: (NAME REDACTED) STARTED HIS PROCEDURES WITH THE ALEXIS O RIDGID. HE NOTICED THE SHEET TEARED. THEN HE STARTED TO USE THE ALEXIS ORTHO. IN 90% OF CASES, HE USES THE ANTERIOR APPOACH AND ALEXIS ORTHO. HE'S USING A RELATIVELY LARGE INCISION. PLACEMENT OF THE SHEET AFTER THE FEMURHEAD IS REMOVED. HE TRIED TO PLACE IT BEFORE BUT HE STATES THAT HE HAS LESS SPACE AND MOVED AWAY FROM THAT. FOR THE OTHER CASES (REVISIONS AND DISPLASIA) HE USES THE LATERAL APPROACH AND NO ALEXIS ORTHO. HE USES A RALATIVELY LARGE INCISION (NO BIKINY INCISION DUE TO MORE WOUND COMPLICATIONS IN RELATION TO STRAIGHT INCISIONS. MORE GRANULATION TUSSUE IN THE GROIN IS SEEN IF BIKINY INCISIONS ARE USED.) ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 28JUN24: 1.IT WAS IN THE MIDDLE OF THE PLASTIC SHEET WERE THE BROACH SOMETIMES CATCHES UP ON THE SHEET (ALEXIS O RIDGID AND ALEXIS ORTHOPEDIC). 2.MALFUNCTION OCCURRED WHEN USING THE BROACH INTO THE FEMUR. 3. DUE TO THE ANGLE OF THE OPERATIONS THE SURFACE OF THE BROACH COMES INTO CONTACT WITH THE SHEET EASILY. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 02JULY24: THE PRODUCT THAT WAS RELATED TO THE TEAR IN THE SHEET WAS THE C8402 ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 08JULY24: ONLY THE ALEXIS O RIDGID HAD A TEAR IN THE SITUATION OF THE [HOSPITAL]. THE CER OF [FACILITY]: BOTH ALEXIS MODELS HAD A TEAR. INTERVENTION: UNKNOWN PATIENT STATUS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977618 ALEXIS O WOUND PROTECTOR-RETRACTOR RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES C8402 UNK 00607915117269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BROACHE| HOHMAN (RETRACTOR)| REAMER