BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT 2.5 L180/155 2FLUTE

    MDR report key: 11595220 · Received March 31, 2021

    Report

    Report Number
    8030965-2021-02471
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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. H3, H6: MRE WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. VISUAL INSPECTION: DRILL BIT Ø2.5 L180/155 2FLUTE (PART# 310.230, LOT# UNKNOWN, QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DISTAL TIP OF THE DEVICE GOT BROKEN. THE BROKEN PIECE WAS RETURNED AT CQ. THE SURFACE OF THE DEVICE SHOWS SOME DISCOLORATION. THE ETCH ON THE DEVICE IS ILLEGIBLE DUE TO THE DISCOLORATION OF THE DEVICE. BUT THE REPORTED EMBEDDED CONDITION OF THE DEVICE CANNOT BE CONFIRMED WITHOUT ANY X-RAY IMAGES. DEVICE FAILURE / DEFECT IDENTIFIED? YES FUNCTIONAL INSPECTION: FUNCTIONAL TESTING OF THE RECEIVED DEVICE WAS NOT PERFORMED DUE TO THE RECEIVED CONDITION OF THE DEVICE. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RELEVANT FEATURE OF THE RECEIVED DEVICE WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DOCUMENT(S) WAS REVIEWED: -DRILL BIT WITH QUICK COUPLING NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? YES BUT THE REPORTED EMBEDDED CONDITION OF THE DEVICE CANNOT BE CONFIRMED WITHOUT ANY X-RAY IMAGES. INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR DRILL BIT Ø2.5 L180/155 2FLUTE (PART# 310.230, LOT# UNKNOWN) AS THE DISTAL TIP OF THE DEVICE GOT BROKEN. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM, IT IS POSSIBLE THAT THE THREADS OF THE SCREW MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    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. 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

    THERE WAS A SURGICAL DELAY OF LESS THAN FIFTEEN (15) MINUTES. THE PATIENT WAS STABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY DUE TO BICOLUMN FRACTURE OF THE RIGHT ACETABULUM. DURING THE SURGERY, WHEN PLACING TWO POSTERIOR SCREWS OF 60 MM LENGTH, THE DRILL BIT BROKE IN THE BONE. 48 MM OF THE DRILL BIT STAYED STUCK INSIDE THE PATIENT, NOT POSSIBLE TO REMOVE IT. USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 60 MM SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DRILL BIT Ø2.5 L180/155 2 FLUTE. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495274 DRILL BIT 2.5 L180/155 2FLUTE DRILL BIT HTW SYNTHES GMBH 310.23 7 2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWS: TRAUMA