BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL APPLIER

    MDR report key: 4963418 · Received August 4, 2015

    Report

    Report Number
    1221934-2015-00896
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY SYNTHES MITEK HOWEVER IT IS NOT KNOWN IT IF WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY SYNTHES MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION OF THE APPLIER REVEALED THE MAIN PUSHER ROD (GREY TRIGGER) WAS SLIGHTLY BENT DOWNWARDS AND STUCK OUTSIDE OF THE END OF THE BARREL OF THE GUN WHICH IS TYPICAL OF AGGRESSIVELY REMOVING THE NEEDLE FOLLOWING USE. WHEN TESTED FOR ITS FUNCTIONALITY, THE RED TRIGGER FUNCTIONED PROPERLY WHEN PULLED ON WITHOUT A NEEDLE ATTACHED TO THE DEVICE. THE NEEDLE ATTACHMENT KEY FEATURE, WHICH ATTACHES THE NEEDLE TO THE APPLIER, HAD NO ANOMALIES. OTHER THAN THIS POSSIBILITY, A ROOT CAUSE FOR THE USER TO HAVE EXPERIENCED THIS FAILURE CANNOT BE DETERMINED. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. HOWEVER, DEPUY SYNTHES (B)(4) WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    WANTING SUTURING WITH OMNISPAN, THE GUN DID NOT WORK AND WHEN FORCING THE GRAY TRIGGER, "STOLE" AND IT COULD NOT BE PUT THE SUTURE AGAIN. THERE WERE NO PATIENT CONSEQUENCES, AND THE PROCEDURE WAS NOT EXTENDED GREATER THAN 30 MINUTES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE VIA EMAIL ON (B)(6) 2015; THE SURGEON REMOVED PART OF THE MENISCUS DUE TO THIS FAILURE. SEE ASSOCIATED MEDWATCH # 1221934-2015-00895.

    Description of Event or Problem · 1

    WANTING SUTURING WITH OMNISPAN, THE GUN DID NOT WORK AND WHEN FORCING THE GRAY TRIGGER, "STOLE" AND IT COULD NOT BE PUT THE SUTURE AGAIN. THERE WERE NO PATIENT CONSEQUENCES, AND THE PROCEDURE WAS NOT EXTENDED GREATER THAN 30 MINUTES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE VIA EMAIL ON 7-21-15; THE SURGEON REMOVED PART OF THE MENISCUS DUE TO THIS FAILURE. SEE ASSOCIATED MEDWATCH # 1221934-2015-00895.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507538 OMNISPAN MENISCAL APPLIER MITEK OMNISPAN MENISCAL APPLIER GEF DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention