BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL

    MDR report key: 7026155 · Received November 13, 2017

    Report

    Report Number
    3000270450-2017-10401
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 19, 2017
    Report Date
    October 19, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZI
    UDI-DI
    07611819353589
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION ACTION & PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE INVESTIGATION SUMMARY INDICATES THAT: SUBJECT DEVICE AS RECEIVED CONDITION: 1X DRILL BIT RECEIVED BROKEN WITHOUT TIP SECTION RETURNED NOT IN ORIGINAL PACKAGE. TAKEN MEASUREMENT ON SHAFT Ø 1.5MM DID CONFORM TO THE SPECIFICATIONS. HARDNESS WAS TESTED BY SUPPLIER SPHINX PRIOR TO DELIVERY AND FOUND TO BE OKAY. COMPLAINT COULD BE CONFIRMED AS TIP OF DRILL BIT IS INDEED BROKEN. REVIEW OF THE MANUFACTURING DOCUMENTS PROVIDED BY SPHINX AG AND THE MEASUREMENT TAKEN COULD NOT PROVIDE ANY EVIDENCE OF A MANUFACTURING RELATED DEVIATION. IT IS LIKELY THAT AN OVERLOADING SITUATION WHILE DRILLING LED TO THE BREAKAGE. NO MANUFACTURING RELATED FAILURE WAS FOUND. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. CONCOMITANT 2X 03.505.003 / 8152686 (SHAFT F/SCREWDRIVER 90°) RECEIVED. FUNCTIONAL CHECK BY HAND SHOWED THAT TURING FUNCTION IS GIVEN. NO FURTHER INVESTIGATION WAS PROVIDED FOR THEM AS NO ALLEGATION WAS MENTIONED. 1X UNK PLATE / 1X UNK SCREW / 1X UNK HANDWHEEL MATERIAL NOT RETURNED. NO INVESTIGATION PROVIDED. 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

    ADDITIONAL DEVICE PRODUCT CODE: DZJ 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 03.505.075, LOT # F-17221: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 10.FEB.2015: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE DRILL BIT WAS BROKEN DURING MANDIBULAR FRACTURE RECONSTRUCTION SURGERY ON (B)(6) 2017. THE SURGEON TRIED TO FIX THE PLATE BY DRILLING A PILOT HOLE BY HANDWHEEL, HOWEVER, THE SURGEON COULD NOT FIX THE PLATE BECAUSE THE SCREW WAS LOOSENED. THE SURGEON USED ELAN HANDPIECE, AESCULAP AS A POWER TOOL. ALSO, IT WAS REPORTED THAT THE DRILL BIT AND SHAFT WERE DETACHED DURING THE SURGERY. THE SURGERY WAS FINISHED ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WAS A UNSPECIFIED AMOUNT OF SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), HANDWHEEL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), SHAFT FOR 90° SCREWDRIVER (PART # 03.505.003, LOT # 8152686, QUANTITY 1) THIS REPORT IS FOR ONE (1) Ø1.5MM DRILL BIT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803549 Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL DRILL, BONE, POWERED DZI SYNTHES SELZACH F-17221 07611819353589

    Patients

    Seq Age Sex Outcome Treatment
    1