BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM UNIVERSAL DRILL GUIDE

    MDR report key: 6904260 · Received September 29, 2017

    Report

    Report Number
    3003875359-2017-10481
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 12, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. (B)(4). LOT NUMBER UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    LOT# AND UDI# . DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 323.360, LOT# 1131493. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUL 17, 2002. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. ONE UNIVERSAL DRILL GUIDE WAS RECEIVED BROKEN FROM THE HANDLE. THE BROKEN DRILL SLEEVE SHOWS MARKS AND WEARS PRESENTING THAT THE 15 YEARS OLD DEVICE HAS BEEN IN FREQUENT USE. BECAUSE OF THE DAMAGE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SEPARATED PARTS HAVE SOLDER LEAVINGS ON BOTH BONDING AREAS WHICH PROVES THAT THE SOLDER BOND MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE EXACT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. WE ASSUME THAT A COMBINATION BETWEEN INTENSE USE, AGE AND A MECHANICAL OVERLOAD DURING USE (AS MENTIONED IN THE COMPLAINT DESCRIPTION) COULD LEAD TO BREAKAGE OF THE DEVICE. AS PER THE DEVICE LEAFLET, END OF LIFE OF A DEVICE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. EVIDENCE OF DAMAGE AND WEAR ON A DEVICE MAY INCLUDE BUT IS NOT LIMITED TO CORROSION (I.E. RUST, PITTING), DISCOLORATION, EXCESSIVE SCRATCHES, FLAKING, WEAR AND CRACKS. IMPROPERLY FUNCTIONING DEVICES, DEVICES WITH UNRECOGNIZABLE MARKINGS, MISSING OR REMOVED (BUFFED OFF) PART NUMBERS, DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY FOR THE PELVIC FRACTURE ON (B)(6) 2017, THE SURGEON TRIED TO USE THE UNIVERSAL DRILL GUIDE IN ORDER TO DRILL THE HOLE ON THE PELVIS; HOWEVER, THE DRILL GUIDE BROKE AT THE MOMENT THE SURGEON APPLIED FORCE. THE BROKEN DEVICE WAS REMOVED EASILY. THE SURGERY WAS COMPLETED SAFELY BY USING ANOTHER DRILL GUIDE. NO DELAY IN SURGERY WAS REPORTED. THERE WAS NO PATIENT HARM, PATIENT STATUS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684218 3.5MM UNIVERSAL DRILL GUIDE GUIDE FZX SYNTHES HAGENDORF 1131493

    Patients

    Seq Age Sex Outcome Treatment
    1