BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    MDR report key: 8748334 · Received July 1, 2019

    Report

    Report Number
    8030965-2019-65897
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819020252
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. THE RECEIVED DRILL BIT IS WORN FORM REGULAR USE AND THEREFORE DULL AS COMPLAINED. NO OTHER DAMAGES ARE VISIBLE. THE COMPLAINT CONDITION IS CONFIRMED AS THE DRILL BIT IS WORN. AFTER A VISUAL INSPECTION PER GUIDANCE, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED.,INVESTIGATION SITE: CQ ZUCHWIL BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART: 315.920 , LOT: F-21129 , MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 22.MAR.2017 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.,PART: 315.920 LOT: F-17809 . MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 11.AUG.2015 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.,PART: 315.920 LOT: F-18109 , MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 26.NOV.2015 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.,PART: 315.920 LOT: F-17481. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 10.NOV.2014 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    POTENTIAL LOT NUMBERS REPORTED AS F-17481, F-18109, F-17809, F-21129. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY DUE TO PELVIC FRACTURE. DURING THE OPERATION, A DRILL BIT WAS NOTED TO BE EXTREMELY DULL. ANOTHER DRILL BIT WAS USED TO COMPLETE THE SURGERY. THE SURGEON COMMENTED THAT AN EXCESSIVE STRESS WAS APPLIED TO THE PELVIS DUE TO THE PROBLEM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY REPORTED. THIS REPORT IS FOR A 2.5MM THREE-FLUTED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540881 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 07611819020252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention