BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ZIP 16 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 23399796 · Received October 28, 2025

    Report

    Report Number
    3015967359-2025-99424
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    January 27, 2026
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    KGX
    UDI-DI
    00865379000019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS) 2 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION 2 DEVICES: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99424. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H1, H6, H11 2 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 2 PREVIOUSLY REPORTED EVENTS IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 3015967359-2025-99429. - 0 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 0 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308146 ZIP 16 SURGICAL SKIN CLOSURE DEVICE TAPE AND BANDAGE, ADHESIVE KGX STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 00865379000019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown