BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø4 F/PFNA

    MDR report key: 4779396 · Received May 18, 2015

    Report

    Report Number
    9612488-2015-10278
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT REPORTED. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: CORRECTED LOT: 2092122 NUMBER, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23. JUNE 2004. 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.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL NARRATIVE: PATIENT AGE WAS REPORTED, BUT PATIENT DATE OF BIRTH IS UNKNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A PRODUCT INVESTIGATION WAS COMPLETED: THE INVESTIGATION OF THE DRILL BIT HAS SHOWN THAT THE TIP IS BROKEN OFF (UNFORTUNATELY THE BROKEN PART REMAINED IN THE BONE, THEREFORE COULD NOT BE RETURNED). THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN DEVICE WAS MANUFACTURED IN JUNE 2004. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IT IS LIKELY THAT A HEAVY EXCEEDING MECHANICAL OVERLOADING SITUATION DURING USE WHICH CAUSED THE BREAKAGE (NO FURTHER DETAILS ARE AVAILABLE). AFTER BREAKING, THE TWO DRILL BIT FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING SLIGHTLY DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AND SHINY AREAS). IT IS RECOMMENDED TO CHECK THE DRILL BIT BEFORE USE (SHARP AND INTACT) IN ORDER TO PREVENT BREAKAGES AND POSSIBLE CONTACT WITH OTHER METALLIC PARTS DURING DRILLING MAY HAVE CAUSED THESE DAMAGES. NO PRODUCT FAULT COULD BE DETECTED. 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PFNA SURGERY, THE DRILL BIT WAS BROKE. A SMALL PIECE REMAINED IN THE PATIENT. NO CONSEQUENCES ON THE PATIENT AFTER THE SURGERY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321784 DRILL BIT Ø4 F/PFNA DRILL, BIT HTW SYNTHES BETTLACH 2092122

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention