BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 4100098 · Received September 18, 2014

    Report

    Report Number
    1221934-2014-00410
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 26, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THAT THE TIP OF THE NEEDLE IS BROKEN, CONFIRMING THIS COMPLAINT. THE BROKEN PIECE WAS ALSO INCLUDED IN THE RECEIVED DEVICE. UPON INSPECTION OF BOTH PARTS OF THE BROKEN NEEDLE, AND COMPARING IT TO A NEW EIII NEEDLE, THERE ARE NO OTHER MISSING PIECES FROM THE COMPLAINT DEVICE, CONFIRMING THAT THERE WERE NO OTHER PIECES POSSIBLY LEFT IN PATIENT. FROM PAST INVESTIGATIONS OF SIMILAR FAILURE MODES, IT HAS BEEN DETERMINED THAT REPEATEDLY PASSING THE NEEDLE THROUGH EXCESS TISSUE CAUSES THE NEEDLE TO FATIGUE AND BREAK. EIII NEEDLES HAVE BEEN DESIGNED TO PASS 15 TIMES THROUGH TISSUE AND ANY USAGE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE. NO FURTHER PROCEDURE INFORMATION WAS PROVIDED TO DETERMINE IF THE ABOVE REASON CONTRIBUTED TO THIS FAILURE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE SIMILAR OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE COMPLAINT RATE HAS BEEN REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED LEVELS. BASED ON THE COMPLAINT HISTORY, NO FURTHER CORRECTIVE ACTION IS WARRANTED AT THIS TIME. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION THAT IS PERTINENT TO THIS ISSUE. DEPUY MITEK 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.

    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 MITEK, HOWEVER MITEK WOULD LIKE TO FILE THIS INITIAL REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP REPORT. AWAITING DEVICE RETURN.

    Description of Event or Problem · 1

    THE FASTIN ANCHOR WAS PUT INTO PLACE DURING AN ARTHROSCOPIC CUFF REPAIR. THE FIRST SUTURE WAS PUT WITH THE EXPRESSEW NEEDLE THROUGH THE BICEPS TENDON (BICEPS TENODESIS WITH THE CUFF REPAIR), AFTER THIS WAS DONE, THE SAME SUTURE WAS RELOADED INTO THE EXPRESSEW III AND PUT THROUGH THE SUPRASPINATUS. AFTER THAT WE SAW A PIECE OF METAL OM THE SCREEN. A PIECE OF THE NEEDLE WAS BROKEN FROM THE NEEDLE. NOTHING STRANGE HAPPENED, THE NEEDLE DID NOT HIT THE ACROMION. THERE IS A POSSIBILITY THAT A PIECE OF THE NEEDLE IS STILL IN THE BODY OF THE PATIENT. THE NEEDLE AND THE PIECE THAT THE SURGEON COLLECTED WILL COME TO YOU, IT LOOKS LIKE IT?S NOT COMPLETE. CHANGE THE NEEDLE AND GET THE PIECE OF NEEDLE THAT WAS BROKEN OF THE NEEDLE OUT OF THE BODY OF THE PATIENT.

    Description of Event or Problem · 1

    THE FASTIN ANCHOR WAS PUT INTO PLACE DURING AN ARTHROSCOPIC CUFF REPAIR. THE FIRST SUTURE WAS PUT WITH THE EXPRESSEW NEEDLE THROUGH THE BICEPS TENDON (BICEPS TENODESIS WITH THE CUFF REPAIR), AFTER THIS WAS DONE, THE SAME SUTURE WAS RELOADED INTO THE EXPRESSEW III AND PUT THROUGH THE SUPRASPINATUS. AFTER THAT WE SAW A PIECE OF METAL OM THE SCREEN. A PIECE OF THE NEEDLE WAS BROKEN FROM THE NEEDLE. NOTHING STRANGE HAPPENED, THE NEEDLE DID NOT HIT THE ACROMION. THERE IS A POSSIBILITY THAT A PIECE OF THE NEEDLE IS STILL IN THE BODY OF THE PATIENT. THE NEEDLE AND THE PIECE THAT THE SURGEON COLLECTED WILL COME TO YOU, IT LOOKS LIKE IT'S NOT COMPLETE. CHANGE THE NEEDLE AND GET THE PIECE OF NEEDLE THAT WAS BROKEN OF THE NEEDLE OUT OF THE BODY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578579 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC SUTURE NEEDLE LXH DEPUY MITEK NA A401030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R