BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULAN LID

    MDR report key: 11455156 · Received March 10, 2021

    Report

    Report Number
    9610612-2021-00168
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    May 25, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: GA672: ATS1607JP, WE ASSUME A REPAIR OR MAINTENANCE IN JP IN 2016. DURING THE FUNCTIONAL TEST, THE MACHINE STARTED BRIEFLY, BUT STOPPED WITHOUT LOAD. WHEN DISASSEMBLED, THE STATOR AND ROTOR WERE NOT TRUE TO GAUGE AND THE STATOR INTERIOR WAS CONTAMINATED. GB636R: VISUALLY, THE PRODUCT IS IN A USED CONDITION. AN ADDITIONAL INSCRIPTION ATS1705JP CAN BE SEEN ON THE SCREW RING, WE ASSUME A REPAIR OR MAINTENANCE IN JP IN 2017. NO DEVIATION COULD BE DETECTED DURING THE FUNCTIONAL TEST.PRODUCT ACCORDING TO SPECIFICATION, HOWEVER, A MAINTENANCE SHOULD BE PERFORMED DUE TO THE OVERDUE MAINTENANCE DATE. GB638R:VISUALLY, THE PRODUCT IS IN A USED CONDITION. THERE IS ADDITIONAL LABELING ON THE SCREW RING WITH ATS1804JP. WE ASSUME A REPAIR OR MAINTENANCE IN JP IN 2018. CLEAR SIGNS OF WEAR CAN BE SEEN ON THE DRILL CHUCK. THEREFORE, A CORRECT TOOL CLAMPING CANNOT BE GUARANTEED ANYMORE. BESIDES THE MENTIONED DRILL CHUCK, THE GB638R IS ACCORDING TO THE SPECIFICATION. NO RUNNING NOISES OR HEATING. GA675: VISUALLY, THE SEALING CAP IS IN A USED CONDITION. FUNCTIONALLY, THE PRODUCT IS ACCORDING TO SPECIFICATION, NO DAMAGE OR SIGNS OF WEAR CAN BE SEEN ON THE HOUSING, LOCKING CLAWS OR SEAL. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    INVOLVED COMPONENT: GB638R - ACCULAN 3TI DRILL ATTACHM.LARGE JACOBS - 51926308 GB636R - ACCULAN 3TI DRILL ATTACHMENT HEXAG.CHUCK - 51872583 GA672 - ACCULAN 3TI DRILL AND REAMER - 51785796 ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00156(400503218 GA672) 9610612-2021-00160400503219 GB636R) 9610612-2021-00159(400503220 GB638R) 9610612-2021-00168(400503660 GA675).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA675-ACCULAN LID. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT DURING THE TKA-NAVI SURGERY, AFTER THE OSTEOTOMY OF THE PROXIMAL TIBIA WAS COMPLETED, WHEN DOCTOR TRIES TO PIN THE DISTAL FEMUR OSTEOTOMY BLOCK, IT ROTATED FOR 1 TO 2 SECONDS AND STOPPED. THE BATTERY AND ATTACHMENT WERE REPLACED, BUT DID NOT IMPROVE. THE SITUATION WHERE IT OPERATED FOR 1 TO 2 SECONDS AND THEN STOPPED CONTINUED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE SUPPORT OF THE OLD ELECTRIC TYPE POWER OF THE HOSPITAL. THIS EVENT/MALFUNCTION PROLONGED THE SURGERY FOR 10 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00156 ((B)(4) + GA672), 9610612-2021-00160 ((B)(4) + GB636R), AND 9610612-2021-00159 ((B)(4) + GB638R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350726 ACCULAN LID POWER SYSTEMS HAB AESCULAP AG GA675

    Patients

    Seq Age Sex Outcome Treatment
    1 GB638R - 51926308GB636R - 518725GA672 - 51785796