BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL BIT W/DEPTH MARK QC/110MM

    MDR report key: 8565253 · Received April 30, 2019

    Report

    Report Number
    8030965-2019-63272
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GFG
    UDI-DI
    07611819158962
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    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 DRILL BIT WAS NOT RETURNED, BUT A PHOTO OF IT WAS RECEIVED ALONG WITH AN X-RAY OF THE SURGICAL SITE IT WAS USED ON. THE TIP OF THE DRILL BIT CAN BE SEEN TO BE MISSING IN ITS PHOTO, CONFIRMING THE FIRST COMPLAINT AGAINST THE DEVICE AS BROKEN. THE SECOND COMPLAINT, THAT THE BROKEN TIP WAS EMBEDDED IN THE PATIENT, CAN ALSO BE CONFIRMED. IN THE GIVEN X-RAY, THE DRILL BIT TIP CAN BE FOUND LODGED IN THE BONE IN THE VICINITY OF THREE UNKNOWN SCREWS HOLDING DOWN A PLATE AT THE END OF THE FIBULA. NO OTHER ISSUES COULD BE IDENTIFIED. A DIMENSIONAL INSPECTION COULD NOT BE PERFORMED SINCE NO DEVICE WAS RETURNED. THE DEVICE WAS MANUFACTURED AT THE BETTLACH SITE ON 08-AUG-2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. THE FIRST COMPLAINT IS CONFIRMED. THE PHOTO OF THE DRILL BIT DEPICTS THE DEVICE WITH A MISSING TIP, BUT NOT THE BROKEN OFF FRAGMENT. THE SECOND COMPLAINT COULD IS CONFIRMED. ON THE PROVIDED X-RAY, THE DRILL BIT FRAGMENT COULD BE LOCATED BURIED INTO THE BONE WHERE A PLATE HAD BEEN AFFIXED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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: 310.534, LOT: 8563518, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 08. AUG. 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. 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: THE DRILL BIT (310.534) WAS RETURNED ON AUGUST 16, 2019 IN ADDITION TO THE PREVIOUSLY RECEIVED X-RAYS. THE TIP OF THE DRILL BIT IS MISSING, CONFIRMING THE FIRST COMPLAINT AGAINST THE DEVICE AS BROKEN. THE SECOND COMPLAINT, THAT THE BROKEN TIP WAS EMBEDDED IN THE PATIENT, CAN ALSO BE CONFIRMED. IN THE GIVEN X-RAY, THE DRILL BIT TIP CAN BE FOUND LODGED IN THE BONE IN THE VICINITY OF THREE UNKNOWN SCREWS HOLDING DOWN A PLATE AT THE END OF THE FIBULA. NO OTHER ISSUES COULD BE IDENTIFIED. THE RELEVANT DRAWINGS WERE REVIEWED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FIRST COMPLAINT IS CONFIRMED. THE DRILL BIT WAS RECEIVED WITH THE TIP BROKEN OFF AND MISSING. THE SECOND COMPLAINT IS CONFIRMED. ON THE PROVIDED X-RAY, THE DRILL BIT FRAGMENT COULD BE LOCATED BURIED INTO THE BONE WHERE A PLATE HAD BEEN AFFIXED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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

    DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. 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 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 A PERONEAL TRANSDERMAL FRACTURE SURGERY. DURING THE SURGERY, THE TIP OF THE DRILL BIT BROKE AND WAS LEFT INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT STATUS WAS OKAY WITH NO COMPLICATIONS ON THE SURGERY. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357804 2.0MM DRILL BIT W/DEPTH MARK QC/110MM BIT MILLING STERILE AND NON GFG OBERDORF SYNTHES PRODUKTIONS GMBH 8563518 07611819158962

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention