BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7118812 · Received December 14, 2017

    Report

    Report Number
    1221934-2017-50063
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 14, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. IT WAS OBSERVED THAT THE NEEDLE WAS BENT ON THE DISTAL END FROM THE NEEDLE TIP. THIS COMPLAINT CAN BE CONFIRMED. A MEMBER OF NEW PRODUCT DEVELOPMENT (NPD) QUALITY THAT IS KNOWLEDGEABLE OF THE FAILURES OF THIS DEVICE WAS CONSULTED FOR INSIGHT INTO THE REPORTED FAILURE. THE NPD QUALITY MEMBER INDICATED THAT THIS TYPE OF FAILURE IS UNUSUAL FOR THIS DEVICE, AND MAY HAVE OCCURRED IF THE NEEDLE WAS FORCED AGAINST BONE. THEREFORE, THE DEVICE WAS POTENTIALLY MISUSED WHICH LED TO THE REPORTED FAILURE. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES WITH THE PRODUCT CODE THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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. UDI: (B)(4) - INCOMPLETE. THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCH REPORT NUMBER: 1221934-2017-50062.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.¿ (B)(4) INCOMPLETE. THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCH:1221934-2017-50062.

    Description of Event or Problem · 1

    NEEDLE BENT WHILE DRILLING THE MENISCUS, NOT BEING ABLE TO USE LATER. THEREFORE, THE DOCTOR OPENED ANOTHER NEEDLE FROM A DIFFERENT LOT AND THE SAME THING HAPPENED. TWO PRODUCTS AFFECTED. ANOTHER PRODUCT WAS USED. PROCEDURE: MENISCUS SUTURE. THERE WAS NO DAMAGE TO THE PATIENT. THE PROCEDURE TIME WAS NOT PROLONGED DUE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896037 RAPIDLOC (PLA/PLA) 2/0 PANACRYL SUTURE WITH 12° CURVE NEEDLE SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK L230324

    Patients

    Seq Age Sex Outcome Treatment
    1