BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DRILL BIT/STRYKER J-LTCHWITH 6MM STOP/44.5MM

    MDR report key: 6067900 · Received October 31, 2016

    Report

    Report Number
    2520274-2016-15130
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 317.66, SYNTHES LOT # U132434, SUPPLIER LOT # U131434. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: MAR 21, 2011. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. CANADA REPORTED THE FOLLOWING EVENT: DURING A PEDIATRIC LEFORT 1 PROCEDURE ON (B)(6) 2016, THE SURGEON WAS USING A 1.5MM DRILL BIT/STRYKER J-LATCH WITH 6MM STOP/44.5MM WITH AN ELECTRIC PEN DRIVE J-LATCH ATTACHMENT TO DRILL HOLES FOR 2.0MM SCREWS IN THE MAXILLA. HE NOTICED THAT THE BLUE PIECE OF TAPE ON THE DRILL BIT PEELED OFF AND A SMALL PIECE FELL INTO THE PATIENT. HE WAS ABLE TO REMOVE THE PIECE OF TAPE USING POWER SUCTION. AS A RESULT THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE SURGERY WAS COMPLETED USING A LIKE SAME/LIKE PRODUCT. NO REPORTED PATIENT HARM. THE RETURNED 1.5MM DRILL BIT (317.66, U132434) WAS RECEIVED IN DECENT CONDITION; HOWEVER THE COMPLAINT CONDITION WAS CONFIRMED AS THE COLOR INDICATOR WAS MISSING. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION, DRAWING REVIEW, ROOT CAUSE ANALYSIS, AND RISK MANAGEMENT ASSESSMENT WERE PERFORMED. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION. IT IS POSSIBLE THAT THE COLOR INDICATOR BECAME SUSCEPTIBLE TO BEING PEELED OFF DUE TO REPEATED USE AND PROCESSING. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: (B)(6) REPORTED THE FOLLOWING EVENT: DURING A PEDIATRIC LEFORT 1 PROCEDURE ON (B)(6) 2016, THE SURGEON WAS USING A 1.5MM DRILL BIT/STRYKER J-LATCH WITH 6MM STOP/44.5MM WITH A ELECTRIC PEN DRIVE J-LATCH ATTACHMENT TO DRILL HOLES FOR 2.0MM SCREWS IN THE MAXILLA. HE NOTICED THAT THE BLUE PIECE OF TAPE ON THE DRILL BIT PEELED OFF AND A SMALL PIECE FELL INTO THE PATIENT. HE WAS ABLE TO REMOVE THE PIECE OF TAPE USING POWER SUCTION. AS A RESULT THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE SURGERY WAS COMPLETED USING A LIKE SAME/LIKE PRODUCT. NO REPORTED PATIENT HARM. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: ELECTRIC PEN DRIVE J-LATCH ATTACHMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPAIR IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718888 1.5MM DRILL BIT/STRYKER J-LTCHWITH 6MM STOP/44.5MM DRILL, BONE, POWERED DZI SYNTHES MONUMENT U132434

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTRIC PEN DRIVE J-LATCH ATCHMNT PT & LOT # UKN.