BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG

    MDR report key: 4928372 · Received July 21, 2015

    Report

    Report Number
    2520274-2015-14971
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Report Date
    July 8, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: THE INITIAL REPORTER PROVIDED LOT NUMBER 3120959 FOR THIS DEVICE. THE PROVIDED LOT NUMBER DOES NOT MATCH THE PART NUMBER (314.68) OF THE DEVICE REPORTED. AT THIS TIME, THE MANUFACTURING LOCATION AND MANUFACTURING DATE ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. 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: SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER, WHICH WAS PREVIOUSLY REPORTED TO BE INVALID, CANNOT BE TRACED. THE MANUFACTURE DATE AND LOCATION ARE THEREFORE UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    PART NUMBER 314.68: A SERVICE AND REPAIR HISTORY REVIEW ((B)(4)) WAS PERFORMED FOR THE RETURNED SCREWDRIVER. NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. FURTHER EVALUATION AT THE CHU SHOWS THAT THIS SCREWDRIVER IS USED FOR SCREW INSERTION ACROSS VARIOUS SYSTEMS. IT WAS REPORTED THAT THE SYNTHES EVALUATION EQUIPMENT FAILED INSPECTION DUE TO THE SCREWDRIVER BEING STUCK IN THE HANDLE AND THAT DURING SEPARATION THE SCREWDRIVER BROKE INTO THREE COMPONENTS. THE HANDLE WAS FOUND BY SERVICE AND REPAIR TO PASS TESTING AND TO BE WORKING WITHIN NORMAL PARAMETERS. THUS, THE HANDLE WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE (B)(4) WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED WITHOUT ADDITIONAL INFORMATION REGARDING THE USER TECHNIQUE AND THE CONDITIONS AT THE TIME OF THE ISSUE, IT IS MOST PROBABLE THAT IT IS A RESULT OF THE METHOD OF USE SINCE THE DEVICES WERE RECEIVED INTACT AND IN FUNCTIONING CONDITION. IN CONCLUSION, THE SCREWDRIVER WAS FOUND TO BE IN GOOD CONDITION, FUNCTIONING WELL, AND DID NOT EXHIBIT ANY UNSPECIFIED FUNCTIONAL ISSUES. AS THERE WERE NO ISSUES IDENTIFIED WITH THE RETURNED SCREWDRIVER, A RISK ASSESSMENT REVIEW ON THIS DEVICE IS NOT APPLICABLE. 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

    IT WAS REPORTED THAT A 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG BECAME STUCK ON A MINIQUICK COUPLING HANDLE. THE DEVICES WERE PULLED APART RESULTING IN DEVICE (SCREWDRIVER BLADE) BREAKAGE. THE INSTRUMENT WAS BROKEN INTO THREE (3) PIECES/COMPONENTS. NO PATIENT OR SURGICAL INVOLVEMENT WAS PROVIDED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473058 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG SCREWDRIVERS HXX SYNTHES USA 3120959

    Patients

    Seq Age Sex Outcome Treatment
    1