BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 4181329 · Received October 17, 2014

    Report

    Report Number
    3000270450-2014-10121
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK012945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE PRESENT DRILL BIT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION (MANUFACTURED SEPTEMBER 2013). THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE GIVEN INFORMATION (DRILLING OVER THE GUIDE WIRE) CLEARLY INDICATES THAT THE DRILL BIT BREAKAGE WAS CAUSED DUE TO THIS INCIDENT. AS PART OF THIS INVESTIGATION THE COMPLAINT DATA BASE WAS REVIEWED AND THERE ARE NO OTHER COMPLAINTS FROM THIS LOT NUMBER AND ARTICLE NUMBER. NO PRODUCT FAULT COULD BE DETERMINED. DATE REPORTED: INITIALLY REPORTED AS (B)(4) 2014. 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 PATIENT IDENTIFIER: (B)(6). ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DRILL BIT GOT BROKEN WHILE DRILLING OVER THE GUIDE WIRE AND PART OF DRILL BIT REMAINS INSIDE THE PATIENT. THE SURGEONS COULDN¿T TAKE IT OUT. IT WAS REPORTED THAT THE PATIENT IS OK. THE DISTAL PART OF THE ITEM GOT BROKEN INTO SMALL FRAGMENTS; THE SURGEON REMOVED IT ALL EXCEPT ONE SMALL PART KEPT INSIDE THE PATIENT. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661243 2.0MM CANNULATED DRILL BIT/QC 150MM SCREW, FIXATION, BONE HWC SYNTHES SELZACH F-14996

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR