BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANT

    MDR report key: 19992727 · Received August 15, 2024

    Report

    Report Number
    1221934-2024-02825
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    February 3, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H10 ADDITIONAL NARRATIVE: G1, G4 (510K), H4: THIS REPORT IS FOR AN UNKNOWN IMPLANT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER, THE EXPIRATION DATE, UDI NUMBER, 510-K NUMBER, MANUFACTURING SITE NAME, AND DEVICE MANUFACTURE DATE ARE UNKNOWN. D9: 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. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KATSMA MS, LAND V, RENFRO SH, CULP H, BALAZS GC. LOW TENSILE STRENGTH SUTURE WITH TRANSOSSEOUS TUNNELS AND SUTURE ANCHORS 5 MM IN DIAMETER OR GREATER ARE ASSOCIATED WITH HIGHER FAILURE RATES IN PRIMARY PATELLAR TENDON REPAIR. ARTHROSC SPORTS MED REHABIL. 2024 FEB 14;6(2):100908. DOI: 10.1016/J.ASMR.2024.100908. PMID: 38469124; PMCID: PMC10925975. OBJECTIVE/METHODS/STUDY DATA: TO DETERMINE THE RATE OF AND RISK FACTORS FOR CLINICAL FAILURE AND RETURN TO MILITARY DUTY FOLLOWING PRIMARY PATELLAR TENDON REPAIR WITH EITHER TRANSOSSEOUS TRUNNEL REPAIR OR SUTURE ANCHOR REPAIR. THE MILITARY HEALTH SYSTEM DATA REPOSITORY (MDR) WAS QUERIED TO IDENTIFY ALL ADULT PATIENTS UNDERGOING SURGICAL TREATMENT OF A PATELLAR TENDON RUPTURE IN THE MILITARY HEALTH SYSTEM FROM 2014 TO 2018. PATIENTS WHO UNDERWENT EITHER TRANSOSSEOUS TUNNEL REPAIR OR SUTURE ANCHOR REPAIR WERE INCLUDED. HEALTH RECORDS WERE EXAMINED TO COLLECT ADDITIONAL DATA. THE SUTURE TYPE THAT WAS UTILIZED IN THE PROCEDURE- WERE DIVIDED INTO HIGH TENSILE STRENGTH SUTURE, COMPOSED OF BRAIDED NONABSORBABLE MATERIAL OVER A COATED CENTRAL CORE (E.G., FIBERWIRE [ARTHREX], ORTHOCORD [DEPUY SYNTHES], ULTRABRAID [SMITH & NEPHEW]) AND LOW TENSILE STRENGTH SUTURE CONSISTING OF BRAIDED MATERIAL ALONE (E.G., ETHIBOND; JOHNSON & JOHNSON). MITEK DEVICES THAT WERE USED IN THIS STUDY: UNK ¿ IMPLANT THE LITERATURE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO ASSOCIATE SPECIFIC ADVERSE EVENTS WITH SPECIFIC DEVICE MANUFACTURERS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CANNOT BE ASSOCIATED WITH A SPECIFIC DEVICE MANUFACTURER DUE TO INSUFFICIENT INFORMATION: -(N=33) REPAIR FAILURE, TREATMENT: REOPERATION -(N=10) SURGICAL SITE INFECTION, TREATMENT: NOT MENTIONED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THIS WAS A RETROSPECTIVE STUDY OF DOZENS OF FACILITIES. NO SPECIFIC LOT NUMBERS ARE AVAILABLE. THERE IS NOTHING TO RETURN. ALL AVAILABLE INFORMATION IS CONTAINED IN THE PAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163501 UNK - IMPLANT UNK - IMPLANT MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention