BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDON STRIPPER, 7 MM

    MDR report key: 16108866 · Received January 5, 2023

    Report

    Report Number
    9610617-2023-00006
    Event Type
    Injury
    Date Received
    January 5, 2023
    Report Date
    March 9, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4). KARL STORZ SE & CO. KG WAS INFORMED THAT THIS DEVICE WAS USED FOR A FURTHER SURGERY. THIS CASE WILL BE HANDLED/REPORTED AS CASE (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TENDON STRIPPER BECAME WORN AFTER APPROX. 50 USES. THIS WORN INSTRUMENT WAS USED FOR SURGERY, THAT TORE 2 TENDONS IN A PATIENT. THIS COULD BE RECOVERED BY A COMPETITOR'S PRODUCT. THE AFFECTED TENDOR STRIPPER WAS SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. THIS EXAMINATION SHOWED THAT THE ARTICLE WAS MANUFACTURED ACCORDING TO THE DRAWING. ACCORDING TO THE DRAWING, THERE IS A 0.1 MM RADIUS ON THE FLAT SURFACE OF THE DISTAL END, WHICH MEANS THAT THE TENDON STRIPPER MUST NOT BE SHARP-EDGED (FIG.3 - 5). A HARDNESS TEST WAS CARRIED OUT TO RULE OUT UNINTENTIONAL WEAR, WHICH SHOWED THAT THE DISTAL HEAD WAS HARDENED ACCORDING TO THE SPECIFICATIONS IN THE DRAWING. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS A USER ERROR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TENDON STRIPPER BECAME WORN AFTER APPROX. 50 USES. THIS WORN INSTRUMENT WAS USED FOR SURGERY, THAT TORE 2 TENDONS. THERE WAS A PROLONGATION OF APPROX. 1H AND A SECOND SURGEON WAS NEEDED. NO FURTHER INFORMATION REGARDING THE STATE OF HEALTH IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188637 TENDON STRIPPER, 7 MM TENDON STRIPPER LXH KARL STORZ SE & CO. KG 28729AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| S