BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE188MM

    MDR report key: 3070710 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10461
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED TO DETERMINE WHETHER THERE WERE ANY ISSUES WHICH COULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT. THE EXAMINATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE FOREFRONT OF THIS INSTRUMENT IS STRONGLY DEFORMED AND HAS A BURR IN THE BORE, CAUSED BY THE DEFORMATION. THERE ARE SEVERAL NICKS AND DENTS AT THE TOP OF THIS INSTRUMENT AND THE LASER MARKING IS WASHED OUT. BASED ON THE AGE AND THE KIND OF THE DAMAGE THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HUMERAL NAIL PROCEDURE, THE SURGEON WAS PUTTING THE INSTRUMENTS TOGETHER AND THE INSTRUMENTS BECAME STUCK TOGETHER. THE SURGEON HAD TO APPLY FORCE IN ORDER TO DETACH THE INSTRUMENTS FROM EACH OTHER. SURGEON THEN INSERTED THE SCREW IN THE PATIENTS BONE THROUGH THE PROTECTION SLEEVE AND THE SCREW WOULD NOT PASS THE END OF THE PROTECTION SLEEVE. THE PROTECTION SLEEVE THEN WOULD NOT RELEASE THE SCREW. SURGEON TRIED PULLING THE PROTECTION SLEEVE OUT TO RELEASE THE SCREW AND THE SCREW PULLED OUT, STRIPPING THE HUMERAL BONE. SURGEON THEN SWITCHED TO A SPIRAL BLADE IMPLANT IN ORDER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO ADVERSE EFFECT TO THE PATIENT. THE PROCEDURE WAS EXTENDED FOR APPROXIMATELY 1 HOUR. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171665 12.0MM/8.0MM PROTECTION SLEEVE188MM LXH SYNTHES BRANDYWINE 4786945

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention