BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE

    MDR report key: 3083783 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10993
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION STATED THAT THE DEVICE MET ALL SPECIFICATIONS. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. PRODUCT DEVELOPMENT EVALUATION STATED THAT A PORTION WAS MISSING FROM THE OUTER PROTECTION SLEEVE. THE OUTER PROTECTION SLEEVE PROVIDES A SOFT, FLEXIBLE PROTECTIVE BARRIER BETWEEN SOFT TISSUE AND MEDICAL INSTRUMENTS & IMPLANTS. THE FLEXIBILITY OF THE PROTECTION SLEEVE ALLOWED IT TO BECOME PARTIALLY INSERTED INTO THE PROXIMAL END OF THE REAMED CHANNEL AND BECAME CAUGHT BETWEEN THE TIBIA AND THE NAIL. THERE IS NO KNOWN WAY TO PROVIDE ENOUGH FLEXIBILITY TO ACCOMMODATE THE BENT NAIL GEOMETRY DURING ENTRY AND PREVENT THE POTENTIAL FOR ENTRY INTO THE OPENING IN THE TIBIA. THE EVALUATION FOUND THE DESIGN IS ADEQUATE FOR INTENDED USE WITH ACCEPTABLE LEVEL OF RISK.

    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.(B)(4)

    Description of Event or Problem · 1

    CONSULTANT REPORTS FOLLOWING INSERTION AND LOCKING OF TIBIAL NAIL EX THROUGH A 12MM SUPRAPATELLAR OUTER PROTECTION SLEEVE, IT WAS NOTICED THAT A SMALL PORTION OF THE SLEEVE WAS BROKEN AND A FRAGMENT WAS MISSING. AFTER SEARCHING THE STERILE FIELD FOR THE MISSING FRAGMENT, IT WAS DETERMINED THAT THE PIECE HAD BEEN RETAINED IN THE PATIENT. USING AN ARTHROSCOPE AND VARIOUS GRASPERS, THE RETAINED FRAGMENT WAS VISUALIZED BEHIND THE PROXIMAL POSTERIOR ASPECT OF THE TIBIAL NAIL, LODGED BETWEEN THE IMPLANT AND THE TIBIA. THE FRAGMENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183352 12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE JDS SYNTHES MONUMENT 6905762

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR