BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILOK QA+#0 OC OS-2

    MDR report key: 20894198 · Received December 10, 2024

    Report

    Report Number
    1221934-2024-04397
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    January 1, 2024
    Report Date
    December 10, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002382
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. D4, H4: THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE EXPIRATION DATE AND DEVICE MANUFACTURE DATE WERE UNKNOWN; AND UDI IS INCOMPLETE.

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE COMPLAINT DEVICE WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT FILE WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH CLINICAL RESEARCH DATA. THE CLINICAL RESEARCH DATA INDICATED A J&J MEDTECH ORTHOPAEDICS PRODUCT FAILURE(S). SINCE THERE WAS NO CONTACT INFORMATION, NO FOLLOW-UP ATTEMPTS COULD BE PERFORMED. IT IS UNKNOWN IF COMPLAINTS DERIVED FROM THIS CLINICAL RESEARCH DATA WERE PREVIOUSLY REPORTED AND DOCUMENTED IN THE J&J MEDTECH ORTHOPAEDICS COMPLAINT SYSTEM AT THE TIME OF OCCURRENCE AS NO PRODUCT CODE/LOT NUMBER INFORMATION WAS PROVIDED TO PERFORM THE SEARCH. GIVEN THAT NO LOT/SERIAL NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE MRE REVIEW WILL BE PERFORMED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER A REVIEW OF CLINICAL DATASET RECEIVED FROM EQUIPE ZORGBEDRIJVEN NEDERLAND B.V. ON CLINICAL OUTCOMES AND COMPLICATIONS AFTER REINSERTION OF THE TRIANGULAR FIBROCARTILAGOUS COMPLEX (TFCC) USING THE MITEK® MINILOK QUICKANCHOR PLUS ANCHOR WITH ORTHOCORD SUTURE. COMPLICATIONS: THREE CASES OF RECURRENT DISTAL RADIOULNAR JOINT INSTABILITY (3%) WERE SCORED AS POSSIBLY RELATED TO THE BONE ANCHOR WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522791 MINILOK QA+#0 OC OS-2 FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 10886705002382

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention