BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANT

    MDR report key: 12898063 · Received November 30, 2021

    Report

    Report Number
    1221934-2021-03504
    Event Type
    Injury
    Date Received
    November 30, 2021
    Report Date
    November 15, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: (510K): THIS REPORT IS FOR AN UNKNOWN IMPLANT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER, 510-K NUMBER AND MANUFACTURING SITE NAME ARE UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS IMPLANTED IN THE PATIENT, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT FILE WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. THE JOURNAL ARTICLE REVIEW INDICATED DEPUY MITEK PRODUCT FAILURE(S). MULTIPLE ATTEMPTS WERE DONE TO OBTAIN MORE INFORMATION FROM THE AUTHOR, HOWEVER, NO RESPONSE WAS RECEIVED. IT IS UNKNOWN IF COMPLAINTS DERIVED FROM THIS JOURNAL ARTICLE WERE PREVIOUSLY REPORTED AND DOCUMENTED IN THE DEPUY MITEK COMPLAINT SYSTEM AT THE TIME OF OCCURRENCE AS NO PRODUCT CODE/LOT NUMBER INFORMATION WAS PROVIDED TO PERFORM THE SEARCH. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED PROBLEM. SINCE NO LOT NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION OR STERILE LOAD REVIEW COULD NOT BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, 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.

    Description of Event or Problem · 0

    THIS FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WORNER, E., ET AL (2021) HIGHER FAILURE RATE OF SUTURE ANCHORS IN PARTIAL DISTAL BICEPS TENDON RUPTURES IN COMPARISON WITH ENDOBUTTON FIXATION. JSES INTERNATIONAL, VOL. 5, PAGES 821-826 (NETHERLANDS). THE STUDY EMPHASIZES ON THE COMPARISON OF THE EB TECHNIQUE WITH SUTURE ANCHORS (SA) FOR PRIMARY REPAIR OF PARTIAL DISTAL BICEPS TENDON RUPTURES. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 59 PATIENTS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: DISTAL BICEPS TENDON REPAIR. THE DEVICES INVOLVED WERE: UNKNOWN QUICK ANCHOR. COMPLICATIONS DESCRIBED: IN ONE PATIENT, SUTURE ANCHORS FAILED AND WERE DETACHED FROM THE BONE AFTER 10 MONTHS. THE OTHER PATIENT HAD PERSISTING ELBOW PAIN AND LOSS OF 30 DEGREES OF SUPINATION AFTER 2 MONTHS BECAUSE OF A HIGH-GRADE RE-RUPTURE. THE OTHER 2 PATIENTS COMPLAINED OF PERSISTING PAIN 3 MONTHS AFTER SURGERY, AND THE MRI SHOWED A MINOR PARTIAL RUPTURE OF THE DISTAL BICEPS TENDON. THE TREATMENT OF THE RE-RUPTURES WAS DIFFERENT BETWEEN PATIENTS. THREE OF 4 PATIENTS WITH A PRIMARY REPAIR WITH SUTURE ANCHORS UNDERWENT REVISION WITH AN EB. ONE PATIENT WAS SUCCESSFULLY TREATED CONSERVATIVELY WITH INTRA-BURSAL INFILTRATION WITH KENACORT (STEROID) AND LIDOCAINE (4:1) AND PHYSICAL THERAPY. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796620 UNK - IMPLANT SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention