BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM DRILL BIT/MQC/75MM

    MDR report key: 12689034 · Received October 25, 2021

    Report

    Report Number
    8030965-2021-08929
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 24, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819394018
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    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. H3, H4, H6- PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT : PART #: 03.114.007, LOT #: U370436, SUPPLIER LOT #: U370436, SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 07 DEC 2020; 04 DEC 2020; 02 DEC 2020; 16 DEC 2020; 08 MAR 2021; 24 MAY 2021. NO NCR'S 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.

    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. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL EXAMINATION FOUND BOTH OF THE RETURNED DRILL BITS APPEAR TO BE BENT. THE EDGES OF THE FLUTES APPEAR TO BE DULL AND WITH VISIBLE NICKS ALONG THE SURFACE. NO OTHER PRODUCT DEFECT IDENTIFIED. A DIMENSIONAL INSPECTION WAS CONDUCTED FOR BOTH OF THE RETURNED DRILL BITS. THE RELEVANT DIMENSIONS WERE FOUND TO BE CONFORMING. BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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 ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT 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 · 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 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 RIGHT FOOT MULTIPLE OSTEOTOMY SURGERY. DURING THE SURGERY, THE SCREW HEAD DOES NOT ATTACH ON THE SCREWDRIVER. THE DRILL BIT IS BENT AND BLUNT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. PATIENT CONSEQUENCE WAS UNKNOWN. THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MQC/75MM . THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592072 1.1MM DRILL BIT/MQC/75MM BIT, DRILL HTW SYNTHES GMBH U370436 07611819394018

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CORTSCR Ø1.5 SELF-TAP L10 SST| SCRDRIVER SHAFT 1.3/1.5 T4 SELF-HOLDING| CORTSCR Ø1.5 SELF-TAP L10 SST| SCRDRIVER SHAFT 1.3/1.5 T4 SELF-HOLDING