BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III NEEDLE

    MDR report key: 3113534 · Received May 15, 2013

    Report

    Report Number
    1221934-2013-00132
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT AWAITING RETURN.

    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. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR 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 COMPLAINT FOR THIS LOT OF 2995 DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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. AS NO INFORMATION WAS AVAILABLE, WE CANNOT CONFIRM IF THIS WAS THE ISSUE IN THIS PROCEDURE. OTHER THAN THE POSSIBILITY OF THIS OCCURRENCE, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. BASED ON THE OVERALL COMPLAINT RATE AND CUSTOMER IMPACT, 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.

    Description of Event or Problem · 1

    THE MATERIALS MANAGER FROM THE FACILITY REPORTED A PORTION ON THE DISTAL TIP OF THE FACILITIES EXPRESSEW SUTURE PASSER NEEDLE BROKE OFF DURING A ROTATOR CUFF PROCEDURE. THE EXPRESSEW GUN WAS NOT FIRING CORRECTLY CAUSING THE SURGEON TO REMOVE THE DEVICE FROM THE PATIENT. ONCE REMOVED, THEY NOTICED THE TIP OF THE NEEDLE WAS BROKEN OFF. IT IS UNCLEAR WHETHER IT BROKE IN THE JOINT SPACE OR NOT. THE SURGEON COULD NOT FIND THE BROKEN FRAGMENT INSIDE OR OUTSIDE OF THE JOINT SPACE MAKING IT POSSIBLE THAT IT IS STILL INSIDE THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH A NEW NEEDLE IN THE SAME EXPRESSEW GUN WITH NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE BROKEN NEEDLE IS COMING BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214300 EXPRESSEW III NEEDLE MITEK ARTHROSCOPIC EQUIPMENT LXH DEPUY MITEK NA A301017

    Patients

    Seq Age Sex Outcome Treatment
    1