BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 4460663 · Received January 28, 2015

    Report

    Report Number
    2520274-2015-10626
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 16, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFYING INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE FSM. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT IT HAS YET TO BE RECEIVED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED ON (B)(6) LOT NUMBER 8780671 1 INVOLVED PART. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE ARTICLE HAS SLIGHT TRACES OF USE ON THE SURFACE. THE MANUFACTURING REVIEW, OF ALL ABOVE MENTIONED ARTICLES, SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WITHOUT ALL INVOLVED PARTS AND THE PROVIDED CLINICAL INFORMATION WE CANNOT DETERMINE THE EXACT ROOT CAUSE. ALSO WE COULD NOT REPRODUCE THE COMPLAINED ISSUE. ALL ARTICLES PASSED THE FUNCTIONAL REQUIREMENTS SUCCESSFULLY AND THEREFORE, THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FIND TO BE WITHIN SPECIFICATIONS. OUR INVESTIGATION SHOWS THAT THERE ARE NO VISIBLE SIGNS OF DAMAGE ON THE ARTICLES. BASED ON THESE RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. ONE PROTECTION SLEEVE 12.0/8.0, LENGTH 188MM FOR WAS RECEIVED FOR MANUFACTURING INVESTIGATION. THE ARTICLE HAS SLIGHT TRACES OF USE WITH SLIGHT SCRATCHES ON THE ARTICLE SURFACE. DURING MANUFACTURING INVESTIGATION, ALL RELEVANT AND SIGNIFICANT CHARACTERISTICS LIKE DIMENSIONS WERE CHECKED AND MEASURED. ALL CHECKED AND MEASURED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. THERE ARE NO REFERENCES TO THE REPORTED ISSUE. 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

    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.THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL INTERFERED WITH THE NAIL WHEN THE SURGEON WAS DRILLING A HOLE OF THE MOST DISTAL END FOR DISTAL LATERAL LOCKING. WITH THE TIP OF THE DRILL BIT LEFT INSIDE THE PATIENT, THE SURGEON TURNED OFF THE POWER TOOL AND MANUALLY PENETRATED THE FAR CORTEX WITH LIGHT HAMMERING. THE DRILL INTERFERED WITH THE NAIL AT THE PROXIMAL HOLE AS WELL. THE SURGEON CONFIRMED THAT BOTH OF THE DRILL BITS HAD NOT BEEN INSERTED INTO THE NAIL HOLES CORRECTLY. THERE WAS A 5-MINUTE DELAY IN THE SURGERY. DUE TO THE UNEXPECTED DRILLING ERROR, THERE IS A HOLE IN THE BONE NEXT TO THE DISTAL LATERAL LOCKING AREA. PATIENT IS CURRENTLY UNDER CLOSE OBSERVATION. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    THE SURGEON CONFIRMED THAT THE DRILL BIT HAD NOT BEEN INSERTED TO THE TWO DIFFERENT NAIL HOLES (BOTH AT THE DISTAL SIDE AND AT THE PROXIMAL HOLES) CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63849 12.0MM/8.0MM PROTECTION SLEEVE 188MM MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8780671

    Patients

    Seq Age Sex Outcome Treatment
    1