BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    MDR report key: 6836455 · Received August 31, 2017

    Report

    Report Number
    9612488-2017-10450
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 10, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    UDI-DI
    07611819775398
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. THE DRILL BITS (PART # 03.010.103, LOT # 8735037 & LOT # 8393880) WERE RECEIVED FOR INVESTIGATION. THE INVESTIGATION HAS SHOWN THAT BOTH DRILL BIT TIPS WERE FOUND BROKEN. FURTHERMORE, THE CUTTING EDGES ARE BLUNT AND THERE ARE NICKS AND WEAR AND TEAR SIGNS ON SURFACE. THE BROKEN PARTS ARE MISSING. 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. AS INDICATED IN THE MANUFACTURING DOCUMENTS FOR LOT 8735037, THE CORRECT MATERIAL WAS USED AND THE HARDNESS WAS WITH THE MEASUREMENT OF 54.5 HRC AND 54.8 HRC WITHIN THE TOLERANCE OF A MINIMUM OF 52 HRC AND MAXIMUM 55 HRC. AS INDICATED IN THE MANUFACTURING DOCUMENTS FOR LOT 8393880, THE CORRECT MATERIAL WAS USED AND THE HARDNESS WAS WITH THE MEASUREMENT OF 52.5 HRC AND 53.0 HRC WITHIN THE TOLERANCE OF A MINIMUM OF 52 HRC AND MAXIMUM 55 HRC. THE MICROSCOPIC VIEW, WITH A MAGNIFICATION OF 10X, OF THE BROKEN SURFACE SHOWS A HOMOGENOUS SURFACE WHAT INDICATES MATERIAL CONFORMITY AS WELL. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE DUE TO MISSING DETAILED CLINICAL INFORMATION AND MISSING BROKEN PART. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. UNFORTUNATELY, WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THIS HAPPENED. BASED ON THE INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES NO PRODUCT FAULT COULD BE DETECTED. CORRECTED DATA: DATE OF EVENT WAS REPORTED AS (B)(6) 2017; HOWEVER IT IS UNKNOWN IF THAT IS THE DATE THE DEVICE BROKE OR THE DATE IT WAS DISCOVERED BROKEN. REPORTER ADDRESS. 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 USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. REPORTERS PHONE NUMBER: (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #03.010.103 / LOT #8735037. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 09.DEC.2013. NO 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. 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: IT WAS REPORTED THAT THE OBTAINED LOAN SET FROM THE DISTRIBUTOR (B)(4) AFTER CHECKING CONTAINS DEFECTIVE DEVICES: DRILL BIT 03.010.103 (BOTH) IS THE LATHE TIP IS BROKEN. DRILL BIT 03.019.016 (BOTH) IS DAMAGE TO THE DRILL, IT IS ASSUMED THAT THESE DRILLS THEMSELVES HAVE BEEN SHARPENED. NO SURGICAL DELAY IS REPORTED. THERE IS NO PATIENT INVOLVED. COMPLAINT INVOLVES 4 PART. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615796 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM BIT,DRILL HTW SYNTHES BETTLACH 8735037 07611819775398

    Patients

    Seq Age Sex Outcome Treatment
    1