BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET MENISCUS MENDER II DISPOSABLE

    MDR report key: 10343541 · Received July 30, 2020

    Report

    Report Number
    1219602-2020-01157
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 9, 2020
    Report Date
    September 17, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWQ
    UDI-DI
    03596010468482
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7209485 DISPOSABLE MENISCUS MENDER II SET USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, THE COMPLAINT COULD NOT BE ULTIMATELY CONFIRMED. DEFINITIVE CONCLUSIONS, ACCURATE INVESTIGATION AND EVALUATION WERE LIMITED WITHOUT EVALUATION OF PHYSICAL PRODUCT. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, PROCEDURE LOCATION AND TISSUE CONDITION. THE INSTRUCTION FOR USE (IFU 1061202) STATES, ¿PRIOR TO USE, INSPECT THE DEVICE TO ENSURE IT IS NOT DAMAGED. DO NOT USE A DAMAGED DEVICE.¿ TO KEEP COMPONENTS FROM SHIFTING WITHIN THE PACKAGE, THE PRODUCT STORAGE CRADLES ARE INTENTIONALLY SNUG. THE HEADS OF THE BRAIDED LOOP COMPONENTS SNAP INTO THEIR PACKAGING CAVITIES TO AVOID INADVERTENT LOOP DISTURBANCE DURING REMOVAL FROM THEIR CRADLES. REMOVAL OF A LOOP FROM THE TRAY USING THE DISTAL END (HEAD) CAN RESULT IN WEAKENING, BENDING OR COMPLETE FRACTURE BETWEEN THE HEAD AND SHAFT. THE MOST SUCCESSFUL METHOD OF RETRIEVAL IS TO PUSH THE HEAD OF THE COMPONENT FROM THE BACK OF THE CRADLE WHICH WILL POP IT FREE. RECENT ENGINEERING EVALUATION CONFIRMED THIS PRODUCT MET SPECIFICATIONS UPON RELEASE. THE PRODUCT FAMILY IS UNDER REVIEW. OCCURRENCE RATE OF ALLEGATIONS ARE MONITORED VIA SURVEILLANCE. IN RESPONSE, ENGINEERING ACTION WAS INITIATED.

    Additional Manufacturer Narrative · 0

    H3, H6: ONE 7209485 DISPOSABLE MENISCUS MENDER II SET WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT CONFIRMED THE COMPLAINT. THE LOOP MENISCAL WERE BROKEN FROM THE BOTTOM. TO AVOID COMPONENTS FROM SHIFTING WITHIN THE PACKAGE, INDIVIDUAL COMPONENT STORAGE CRADLES ARE INTENTIONALLY SNUG. USE OF THE DISTAL END (HEAD) TO REMOVE SNARE LOOPS FROM THE TRAY MAY RESULT IN WEAKENING, BENDING OR COMPLETE FRACTURE BETWEEN AT THE HEAD AND SHAFT CONNECTION. PROPER METHOD OF RETRIEVAL IS TO PUSH AND POP THE HEAD OF THE COMPONENT FROM THE BACK OF THE CRADLE. COMPLAINT HISTORY REVIEW INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION ALTHOUGH THE CONDITION WAS CONFIRMED DURING FURTHER INVESTIGATION BY ENGINEERING. ENGINEERING EVALUATION CONFIRMED THE PRODUCT MET SPECIFICATIONS AT THE TIME OF DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE MENISCUS MENDER WAS BROKEN. INCIDENT OCCURRED BEFORE A MENISCAL REPAIR PROCEDURE. THERE WAS A DELAY OF 0-30 AND MIN AND THERE WAS A BACK-UP DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809374 SET MENISCUS MENDER II DISPOSABLE PASSER HWQ SMITH & NEPHEW, INC. 7209485 2034277 03596010468482

    Patients

    Seq Age Sex Outcome Treatment
    1