BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 3823620 · Received May 21, 2014

    Report

    Report Number
    9612488-2014-10181
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS 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. 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. ADDITIONAL NARRATIVE: TIP OF THE REAMER IS BROKEN OFF. OUR INVESTIGATION SHOWS THAT BOTH INSTRUMENTS ARE BADLY DAMAGED AND WORN OUT. THE ARTICLE 352.040 HAS HEAVY MARKS AND STRIATIONS AT THE SHAFT. THE ACCOMPANYING ARTICLE 352.085 IS BROKEN OFF AND THE CUTTING EDGES ARE COMPLETELY BLUNT. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE OF BOTH INSTRUMENTS WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. DUE TO THE WEAR AND TEAR SIGNS, IT APPEARS THAT THIS PRODUCT WAS AN OFTEN AND INTENSIVELY USED INSTRUMENT. THE BAD CONDITION OF THE DEVICE IN COMBINATION WITH AN APPLICATION OF HIGH MECHANICAL FORCE ON IT DURING THE SURGERY COULD FINALLY LEAD TO THE COMPLAINED ISSUE. 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 TOOLS REQUIRES MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE IT IS RECOMMENDED 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF SYNREAM FLEXIBLE SHAFT IS DAMAGED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301780 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 2642058

    Patients

    Seq Age Sex Outcome Treatment
    1