BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANALOK RC QA+DS SUTURE PANACRYL

    MDR report key: 6867799 · Received September 15, 2017

    Report

    Report Number
    1221934-2017-10512
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 11, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. UDI: (B)(4). THE LOT EXPIRATION DATE IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING CLOSED SINCE AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE PRODUCT, THE PRODUCT STILL HAS NOT BEEN RETURNED FOR EVALUATION. IF AND WHEN THE DEVICE IN QUESTION IS RECEIVED, THIS FILE WILL BE REOPENED AND ITS CONTENTS MADE TO REFLECT THE RESULTS OF THE EVALUATION. A DEFINITIVE ROOT CAUSE FOR THIS SPECIFIC DEVICE FAILURE CANNOT BE DETERMINED. A DHR 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 DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR OR DISSIMILAR COMPLAINTS OF ANY TYPE FOR THIS LOT NUMBER THAT WAS RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THAT THE ANCHOR DEPLOYED INTO BONE AND WHEN SURGEON CHECKED STABILITY OF THE ANCHOR THE SUTURES POPPED OUT. ANOTHER ANCHOR HAD TO BE DEPLOYED IN A SECOND HOLE AND A SUCCESSFUL REPAIR OCCURRED. SURGEON IS VERY EXPERIENCED WITH THIS ANCHOR AND THIS HAS NOT HAPPENED BEFORE. THERE WAS A SLIGHT DELAY IN THE CASE BUT NO EFFECT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 9-14-2017: ALERT DATE IS (B)(6) 2017. THIS WAS ERRONEOUSLY LOGGED BY THE PRODUCT SPECIALIST IN THE INCORRECT SYSTEM (IN TVA) AND DID NOT COME TO THE ATTENTION OF PRODUCT SAFETY UNTIL 12TH SEPTEMBER. NO DELAY OF GREATER THAN 30 MINUTES. NO EFFECT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649645 PANALOK RC QA+DS SUTURE PANACRYL MITEK ANCHOR IMPLANTS MAI DEPUY MITEK L185616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other