BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE BATTERY POWERED DRIVER

    MDR report key: 19721445 · Received July 11, 2024

    Report

    Report Number
    8030965-2024-08528
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819890084
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: B3: UNKNOWN EVENT DATE: E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. H3, H4, H6 INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT ON UNKNOWN DATE THE ITEM HAND PIECE FOR BATTERY POWERED DRIVER DOES NOT SPIN OR TURN ON. THE REPAIR TECHNICIAN REPORTED FAST FORWARD, FORWARD ,REVERSE DOES NOT RUN AND CRACK CONTACT PLATE AND DISCOLOR MEMBRANE VENT ALSO DISCOLOR WIRE AND DEBRIS ON INTERNAL COMPONENT WAS FOUND . THE CAUSE OF THE ISSUE IS FAULTY PART. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 08 JULY 2024 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN MDS&R. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY PART:05.000.008 SYNTHES LOT:003565 SUPPLIER LOT:003565 RELEASE TO WAREHOUSE DATE: JUL 09, 2010 SUPPLIER: (B)(4) NCRS WERE GENERATED DURING PRODUCTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON UNKNOWN DATE THE ITEM HAND PIECE FOR BATTERY POWERED DRIVER DOES NOT SPIN OR TURN ON. IT WAS UNKNOWN WHEN THE INCIDENT WAS OBSERVED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THIS REPORT IS FOR ONE HANDLE BATTERY POWERED DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386045 HANDLE BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 07611819890084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown