BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/

    MDR report key: 19055323 · Received April 5, 2024

    Report

    Report Number
    8030965-2024-04616
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 22, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819351813
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT UNKNOWN SURGERY WITH A PHILOS MIPO DEVICE. WHILE PERFORMING INTERNAL FIXATION, IN A DRILL SLEEVE, DRILL BIT BROKE OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN EXTRA 30 MINUTES. POSTOPERATIVE X-RAY CONFIRMED THERE WAS NO RESIDUE IN PATIENT¿S BODY. ACCORDING TO OPERATOR, THE DRILL WAS PULLED OFF TOWARD STANDARD ROTATION DEPENDING ON IT TOOK EXTRA FORCE, ACCORDINGLY ITS BIT WAS LIKELY STUCK IN SLIT IN SLEEVE, SO THE CONDITIONS LIKELY WAS BLAME. THE PATIENT STATUS/ OUTCOME WAS REPORTED AS STABLE. OUR SALES REP CONVINCED THE GRIEVANCE WHICH STEMMED FROM SURGEON¿S POOR TECHNIQUE. ADDITIONALLY, BROKEN BIT WAS REPORTED AS STILL TIGHTLY GETS STUCK IN SLEEVE, AND TAKING IT AWAY APPEARED TO BE HARD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/ THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546371 DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/ BIT, DRILL HTW SYNTHES GMBH 07611819351813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DRILLSL Ø2.5 F/NEUTRAL POSITION PERCUT