BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDLOC (PLA/PDS) 2/0 PANACRYL 12° CURVE NEEDLE

    MDR report key: 3970489 · Received July 31, 2014

    Report

    Report Number
    1221934-2014-00322
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 3, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K023388
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK RECEIVED THE COMPLAINT DEVICE AND EVALUATED IT VISUALLY. VISUALLY, IT WAS OBSERVED THAT THE BACKSTOP AND TOP HAT WERE RECEIVED UNLOADED OFF THE NEEDLE. THE PDS TOP HAT, KNOT AND THE PLA BACKSTOP ARE INTACT ON THE SUTURE WERE RECEIVED FOR ONE DEVICE AND THE TOP HAT WAS MISSING FOR THE SECOND DEVICE. IT WAS OBSERVED ON BOTH CASES THAT THE SUTURE IS BROKEN, CONFIRMING THIS COMPLAINT. BASED ON THE FRAYING ON THE SUTURE, IT IS POSSIBLE THAT AN INSTRUMENT USED IN THE PROCEDURE CAUSED THIS FAILURE. FOR EXAMPLE, IF THE INSTRUMENT IS USED WITH A MORE ABRASIVE SUTURE THAN ORTHOCORD IT MAY LEAVE ABRASIONS ON THE INSTRUMENT, OR IF THE INSTRUMENT RECEIVES AN IMPACT ON THE DISTAL TIP, THAT ALSO COULD LEAVE A SHARP EDGE ON THE INSTRUMENT. OTHER THAN THIS POSSIBILITY WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. 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 DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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 DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY 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. IN TRANSIT.

    Description of Event or Problem · 1

    THE MATERIAL MANAGER FROM THE FACILITY REPORTED THE TOGGLE SWITCH ON THEIR 12 DEGREE RAPIDLOC NEEDLE BROKE OFF DURING A MENISCAL REPAIR. THE SURGEON USED ANOTHER NEEDLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. IT IS UNCLEAR WHETHER ANY PART OF THE NEEDLE ACTUALLY BROKE OFF INTO THE PATIENT. ADDITIONAL INFORMATION IS BEING GATHERED. UPDATE: UNABLE TO REACH CUSTOMER AFTER ATTEMPTING 3 FOLLOW UPS VIA TELEPHONE TO OBTAIN ADDITIONAL INFORMATION. TO THE BEST OF OUR KNOWLEDGE, THERE IS NO "TOGGLE SWITCH" ON THE DEVICE. ASSUMING THE CUSTOMER IS REFERRING TO THE TOP HAT OF THE DEVICE WE ARE FILING A MALFUNCTION THIS TIME TO STAY CONSISTENT AND CONSERVATIVE. SEE ASSOCIATED MEDWATCH# 1221934-2014-00321 FOR THE FIRST NEEDLE REPORTED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE MATERIAL MANAGER FROM THE FACILITY REPORTED THE TOGGLE SWITCH ON THEIR 12 DEGREE RAPIDLOC NEEDLE BROKE OFF DURING A MENISCAL REPAIR. THE SURGEON USED ANOTHER NEEDLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. IT IS UNCLEAR WHETHER ANY PART OF THE NEEDLE ACTUALLY BROKE OFF INTO THE PATIENT. ADDITIONAL INFORMATION IS BEING GATHERED. UPDATE: UNABLE TO REACH CUSTOMER AFTER ATTEMPTING 3 FOLLOW UPS VIA TELEPHONE TO OBTAIN ADDITIONAL INFORMATION. TO THE BEST OF OUR KNOWLEDGE, THERE IS NO 'TOGGLE SWITCH' ON THE DEVICE. ASSUMING THE CUSTOMER IS REFERRING TO THE TOP HAT OF THE DEVICE WE ARE FILING A MALFUNCTION THIS TIME TO STAY CONSISTENT AND CONSERVATIVE. SEE ASSOCIATED MEDWATCH# 1221934-2014-00321 FOR THE FIRST NEEDLE REPORTED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447615 RAPIDLOC (PLA/PDS) 2/0 PANACRYL 12° CURVE NEEDLE SOFT-TISSUE ANCHOR, BIODEGRADABLE JDR DEPUY MITEK NA 3736410

    Patients

    Seq Age Sex Outcome Treatment
    1