BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL FOR BPL II

    MDR report key: 23868508 · Received December 22, 2025

    Report

    Report Number
    8030965-2025-12854
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 22, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    UDI-DI
    07611819491830
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE DEVICE WAS FUNCTIONALLY / VISUALLY TESTED ACCORDING TO THE SERVICE MANUAL. THE DESCRIBED FAILURE BY THE CUSTOMER COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY INSPECTED AS RECEIVED FROM THE CUSTOMER. IT WAS FOUND THAT THE DEVICE FAILED VISUAL INSPECTION. DUE TO DAMAGED CAP. FOLLOWING TEST FAILED ACCORDING TO THE PRE-DIAGNOSTIC ASSESSMENT: GENERAL CONDITION: FAIL. CHECK CANNULATION: FAIL. CHECK FOR STICKY TRIGGER: FAIL. MODE SWITCH-TEST N/A. FOLLOWING FAILURE COULD BE IDENTIFIED: THE DEVICE WAS VISUALLY AND FUNCTIONALLY ASSESSED, AND IT WAS FOUND THAT THE DEVICE FAILED VISUAL INSPECTION DUE TO DAMAGED CAP. BECAUSE OF THE DAMAGED CAP A K-WIRE COULD NOT BE INSERTED. THE FOUND DAMAGED CAP IS CONSISTENT WITH BEING DROPPED OR HIT AGAINST OR HIT WITH ANOTHER OBJECT. FURTHERMORE, IT WAS DETECTED THAT THE TRIGGER WAS STICKY. ROOT CAUSE COMMENTS: THE MOST PROBABLE ROOT CAUSE CAN BE TRACED TO IMPROPER HANDLING AND IMPROPER MAINTENANCE. AS PART OF SYNTHES QUALITY PROCESS ALL DEVICES ARE SERVICED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE IFU STATES THE FOLLOWING REGARDING THE REPORTED ISSUE THAT WAS OBSERVED BY THE USER OR CUSTOMER: TO ENSURE A LONG SERVICE LIFE AND SMOOTH OPERATION, IT IS NECESSARY THAT THE ACCESSIBLE MOVING PARTS OF THE HANDPIECE, BATTERY CASING AND ATTACHMENT ARE LUBRICATED AFTER EACH USE WITH 1 DROP OF SYNTHES SPECIAL OIL. THE FOLLOWING INDIVIDUAL PARTS MUST BE LUBRICATED WITH 1 DROP OF SYNTHES SPECIAL OIL (519.970, 519.97*): 1 ATTACHMENT RELEASE RING (FIGS.1A AND 1B) 2 TRIGGER SHAFT. AFTER APPLICATION OF LUBRICANT PRESS THE TRIGGER SEVERAL TIMES 3 REAR END OF THE CANNULATION (FIG.3) ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY REAMER DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN OIL LIKE STAIN ON THE NONWOVEN FABRIC UNDERNEATH THE DEVICES. THE EVENT OF STICKY TRIGGER DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786006 BATTERY REAMER/DRILL FOR BPL II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES GMBH 07611819491830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown