BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM DRILL BIT/MQC/75MM

    MDR report key: 12550498 · Received September 29, 2021

    Report

    Report Number
    8030965-2021-08142
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 1, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. VISUAL INSPECTION: THE DRILL BIT Ø1.1 L75/61 2FLUTE (P/N: 03.114.007, LOT #: U370436) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE DRILL BIT WAS OBSERVED TO BE DULL AND BENT. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS NOT PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. HOWEVER, THE DRILL BIT WAS SEEN TO BE DULL WHICH COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. DIMENSIONAL INSPECTION: DRAWING: 03_114_007, REV. B SPECIFIED DIMENSIONS: SHAFT DIAMETER =1.1 MM +0.010 MM/-0.014 MM MEASURED DIMENSIONS: SHAFT DIAMETER = 1.096 MM DEVICE USED - OM521. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED DIA 1.1 MM X 75 MM DRILL BIT: 03_114_007, REV. B INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE RECEIVED DEVICE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 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 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART #: 03.114.007. LOT #: U370436. SUPPLIER LOT #: U370436. SUPPLIER: ORCHID UNIQUE. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE DRILL BITS DID NOT HAVE A GOOD CUT AND IN ADDITION TO THIS, THE SPECIALIST COMPLAINS THAT DRILLING IS DIFFICULT BECAUSE THE BITS ARE LONG. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448514 1.1MM DRILL BIT/MQC/75MM BIT, DRILL HTW SYNTHES GMBH U370436 07611819394018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown