BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    MDR report key: 5015117 · Received August 19, 2015

    Report

    Report Number
    2520274-2015-15308
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 15, 2014 NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 323.062, 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM, LOT NUMBER 9203489). THE INVESTIGATION SHOWS THAT THE DRILL BIT IS BROKEN AT THE FLUTE. ADDITIONALLY IT WAS OBSERVED THAT THE CUTTING EDGES ARE BLUNT. 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. UNFORTUNATELY, THE EXACT CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED. DUE TO THE WEAR AND TEAR SIGNS, IT IS LIKELY THAT THIS PRODUCT WAS USED OFTEN AND INTENSIVELY. IT IS HIGHLY PROBABLE THAT THE CAUSE OF THE BREAKAGE IS THE RESULT OF A MECHANICAL OVERLOAD SITUATION DURING USE. THE BAD CONDITION OF THE DEVICE, BEFORE SURGERY, MAY ALSO HAVE PLAYED A CONTRIBUTORY NEGLIGENCE TO THE FRACTURE. THE MICROSCOPIC ANALYSIS OF THE BROKEN SURFACE SHOWS A HOMOGENOUS SURFACE WHAT INDICATES MATERIAL CONFORMITY. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE RECOMMEND THAT BLUNT OR DAMAGED INSTRUMENTS NEED TO BE EXCHANGED BEFORE SURGERY. 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: THE REPORTED 2.0 MM DRILL BIT WITH DEPTH MARK WAS BROKEN DURING DRILLING THE LATERAL SUPPORT PART OF VARIABLE ANGLE DISTAL HUMERUS PLATE (VA-DHP). HOWEVER, THE BROKEN DRILL BIT WAS EASILY REMOVED BECAUSE THE BROKEN PART WAS NOT INSIDE THE PATIENT'S BODY. THE SURGERY WAS COMPLETED WITHOUT PATIENT HARM. NO SURGICAL DELAY WAS REPORTED. THE SURGEON COMMENTED CAUSE OF THE BREAKING MIGHT BE COMING FROM TOO MUCH TENSION AT DRILLING STARTED, OR TOO HARD BONE DUE TO ALLOGRAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549312 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BIT, DRILL HTW SYNTHES BETTLACH 9203489

    Patients

    Seq Age Sex Outcome Treatment
    1