BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM AUTOPASS NEEDLE, QTY 5

    MDR report key: 15363364 · Received September 6, 2022

    Report

    Report Number
    1017294-2022-00090
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 22, 2022
    Report Date
    October 26, 2022
    Manufacturer
    CLASSIC WIRE CO. INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT IS CONFIRMED. CUSTOMER EVENT ¿DISPOSABLE NEEDLE CAME OFF AT SOME POINT DURING USE¿ WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD CANNOT NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 COMPLAINTS, REGARDING 12 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO AVOID LATERAL STRESSES TO THE INSTRUMENT OR DEVICE FUNCTION MAY BE COMPROMISED. DO NOT USE IF PARTS ARE BROKEN, CRACKED OR WORN, OR DEVICE FUNCTION MAY BE COMPROMISED. IF THE SUTURE PASSER NEEDLE KINKS DURING USE, IMMEDIATELY DISCONTINUE USE AND DISCARD. THERE IS AN INCREASED RISK OF NEEDLE BREAKAGE AND UNINTENTIONAL PATIENT INJURY MAY RESULT. DO NOT USE BEYOND THE EXPIRATION DATE LISTED ON THE LABEL. THE PERFORMANCE, SAFETY, AND/OR STERILITY OF THE DEVICE CANNOT BE ASSURED BEYOND THE EXPIRATION DATE. DO NOT USE DISPOSABLE SUTURE PASSER NEEDLE FOR MORE THAN ONE (1) PROCEDURE. REUSE COULD CAUSE FATIGUE AND/OR BREAKAGE OF THE NEEDLE, WHICH MAY CAUSE POSSIBLE PATIENT INJURY. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SMI-02N, SPECTRUM AUTOPASS NEEDLE, QTY 5 WAS BEING USED ON (B)(6) 2022 DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED ¿THE TIP OF THE DISPOSABLE NEED CAME OFF AT SOME POINT DURING USE. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED, AND THE TIP OF THE NEEDLE WAS NOT RETRIEVED "WE DID NOT NOTICE IT UNTIL THE NEEDLE FAILED TO PUNCTURE THE TISSUE DURING NEXT SUTURE PASSING ATTEMPT. WE ARE NOT SURE IF THE NEEDLE TIP FRAGMENT WAS RETRIEVED. WE DID NOT VISIBLY SEE IT ON THE SCREEN; THEREFORE, NO ATTEMPT WAS MADE TO LOCATE IT WITHIN THE PATIENT. WE LOOKED AT THE SURROUNDING AREAS BUT FAILED TO LOCATE THE PIECE.¿ THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY AND THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORTED MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO NEEDLE FRAGMENTATION.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SMI-02N, SPECTRUM AUTOPASS NEEDLE, (B)(4) WAS BEING USED ON (B)(6) 2022 DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED ¿THE TIP OF THE DISPOSABLE NEEDLE CAME OFF AT SOME POINT DURING USE. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED, AND THE TIP OF THE NEEDLE WAS NOT RETRIEVED "WE DID NOT NOTICE IT UNTIL THE NEEDLE FAILED TO PUNCTURE THE TISSUE DURING NEXT SUTURE PASSING ATTEMPT. WE ARE NOT SURE IF THE NEEDLE TIP FRAGMENT WAS RETRIEVED. WE DID NOT VISIBLY SEE IT ON THE SCREEN; THEREFORE, NO ATTEMPT WAS MADE TO LOCATE IT WITHIN THE PATIENT. WE LOOKED AT THE SURROUNDING AREAS BUT FAILED TO LOCATE THE PIECE.¿ THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY AND THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORTED MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO NEEDLE FRAGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806047 SPECTRUM AUTOPASS NEEDLE, QTY 5 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CLASSIC WIRE CO. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other