BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTOR TOOTHED Ø 2MM

    MDR report key: 14787266 · Received June 23, 2022

    Report

    Report Number
    9611102-2022-00024
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 16, 2022
    Report Date
    February 23, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HWE
    UDI-DI
    04055207038154
    PMA / PMN Number
    K080617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (DEVICE MANUFACTURER). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: B4, D4, G3, G6, H2, H3, H6 (CLINICAL CODE, IMPACT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), AND H10. CORRECTED DATA: D2 (COMMON DEVICE NAME), D9(DATE RETURNED TO MANUFACTURER), AND H1(TYPE OF REPORTABLE EVENT). ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER CLAIMING THAT WITHIN A FEW MONTHS, ANOTHER COMPARABLE CASE (SUBSEQUENT MDR 9611102-2022-00044, (B)(4)) OCCURRED WITH A RESECTOR FROM THE SAME BATCH. IN BOTH CASES, THE INNER KNIFE GOT CAUGHT IN THE WINDOW OF THE OUTER KNIFE DURING THE ROTATIONAL MOVEMENT. DUE TO THE ABRUPT STOP OF THE INNER KNIFE, THE LOAD LIMIT WAS SUBSEQUENTLY EXCEEDED AND ULTIMATELY A SECTION BROKE OFF. IN BOTH CASES, THE SECTION COULD BE REMOVED FROM THE PATIENT. DURING THE INSPECTION OF THE RESECTOR TOOTHED Ø 2MM 899710032, BATCH # 0608202102 BY RICHARD WOLF GMBH, IT IS DETERMINED IN ACCORDANCE WITH TEST INSTRUCTIONS THAT THE SECTION BROKE OFF DUE TO USING EXCESSIVE FORCE AND PRESSURE ON THE DEVICE. THE RESECTOR TOOTHED Ø 2MM 899710032, BATCH # 0608202102 WAS PRODUCED ON 06/AUG/2021, THE BATCH CONSISTED OF 22 RESECTORS. IN TOTAL, 4 RESECTORS WERE DELIVERED TO THE CUSTOMER, LAST DELIVERY OF 2 RESECTORS WAS ON (B)(6) 2022. IN THE REVIEW PERIOD OF (B)(6) 2019 AND (B)(6) 2022, THERE WAS NO FURTHER COMPLAINTS REGARDING THE RESECTORS EXCEPT THE 2 COMPLAINTS FROM THIS USER. THE IFU GA-A238-US / EN / 2020-12 V6.0 / PK20-0352 CONTAINS SEVERAL SAFETY NOTES OF AVOIDING EXCESSIVE FORCE IN USE OF THE DEVICE IN SECTION 1.5 GENERAL NOTES AND INSTRUCTIONS FOR USE AND IN SECTION 5.4 OPERATION OF DEVICE. THE SUBJECT ISSUE OF AVOIDING EXCESSIVE FORCE IN USE OF THE DEVICE IS PRESENT IN THE RISK MANAGEMENT FILE E5-4 - REUSABLE TOOLS, REV. 05. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    DURING WRIST ARTHROSCOPY, THE SHAVER (INNER KNIFE) BROKE OFF DISTALLY IN THE AREA OF THE WRIST CAPSULE. UNDER X-RAY CONTROL, THE BROKEN PIECE WAS REMOVED. ACCORDING TO THE ATTENDING SURGEON, THIS REQUIRED AN ADDITIONAL 45-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401006 RESECTOR TOOTHED Ø 2MM RESECTOR TOOTHED Ø 2MM HWE RICHARD WOLF GMBH 899710032 0608202102 04055207038154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other