BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM

    MDR report key: 8759435 · Received July 3, 2019

    Report

    Report Number
    8030965-2019-65995
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 6, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819690608
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.130.202, LOT: F-23257, MANUFACTURING SITE: SELZACH, SUPPLIER: SPHINX WERKZEUGE AG, RELEASE TO WAREHOUSE DATE: 23.OCT.2017. THE CERTIFICATE OF CONFORMITY SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS. NCR # NR-0073082 WAS GENERATED DURING PRODUCTION. THIS PLANNED NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION, THE NON-CONFORMANCE IS FOR RE-ORGANIZING THE ORTHOPEDIC INSTRUMENTATION SUPPLY CHAIN OF DEPUY SYNTHES. NR-0073082 IS ALLOWING THE REVISION OF THE PRODUCT DRAWING FOR THE NEW SUPPLIER WHILE STILL MANUFACTURING AT THE PREVIOUS REVISION FOR THE INCUMBENT SUPPLIER SPHINX. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE TIP OF THE DRILL BIT IS BROKEN OFF AS COMPLAINED. APPROX. 6MM OF THE DISTAL CUTTING TIP SECTION HAS BROKEN OFF AND WAS NOT RETURNED FOR INVESTIGATION. THE FRACTURE ANGLE IS OBLIQUE. BESIDES, THE INSTRUMENT PRESENTS NORMAL SIGNS OF USE. DIMENSIONAL INSPECTION: THE OUTSIDE DIAMETER MEASURED NEAR THE BREAKAGE AND IT COMPLY WITH THE SPECIFICATIONS. FURTHER DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. MATERIAL /HARDNESS REVIEW: THE REVIEW HAS SHOWN THAT WITH 1.4112 STAINLESS STEEL THE CORRECT MATERIAL WAS USED, AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 600 +55 HV10 FROM DRAWING SE_491516 REV B. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE TIP OF THE DRILL BIT IS BROKEN. THIS PRODUCTION LOT (F-23257) WAS MANUFACTURED IN OCTOBER 2017 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATIONS. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIAS. A DEFINITIVE ROOT CAUSE FOR THE DRILL BIT BREAKING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE OBLIQUE FRACTURE ANGLE SUGGESTS OFF AXIS FORCE HAS CONTRIBUTED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. CONCOMITANT MEDICAL DEVICES. 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

    ADDITIONAL CONCOMITANT DEVICE: POWER PRO DRILL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: DEVICE RECEIVED. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. DEVICE THAT BROKE INTRAOPERATIVELY OR IN SURGERY. THE BROKEN PART HAS SEPARATED INTO 2 OR MORE PIECES. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; 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) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TO TREAT A HAND FRACTURE, THE SURGEON DRILLED THE BONE WITH A DRILL BIT THROUGH AN UNKNOWN DRILL GUIDE. THE DRILL BIT BROKE AND THE BROKEN PIECE REMAINED IN THE PATIENT'S BODY. THE SURGEON TRIED TO REMOVE THE BROKEN PIECE, HOWEVER, FAILED. THE SURGEON DECIDED TO LEAVE THE BROKEN PIECE IN THE PATIENT'S BODY. AS PART OF THE TREATMENT PLAN, ONCE THE BONE HEALING OCCURS, A RE-OPERATION TO REMOVE AN UNKNOWN PLATE WILL BE PERFORMED AND THE SURGEON WILL BE RETRIEVING THE BROKEN PIECE OF THE DRILL BIT FROM AN OPPOSITE DIRECTION.  THERE WAS A SURGICAL DELAY OF 30 MINUTES.  THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1), UNKNOWN DRILL GUIDE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550594 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM BIT DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH F-23257 07611819690608

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention UNK - GUIDES/SLEEVES/AIMING| UNK - PLATES| UNK - POWER PRO DRILL