Additional information/clarification was received on 20 october 2022 reporting for the procedure on (b)(6) 2022, prior to finding out there was a hole in the blue wrap, the patient was not under anesthesia as previously reported.The tray was taken to the sterile processing department to be reprocessed.The surgery start time was delayed about an hour and 15 minutes before the patient was put under anesthesia and the procedure began.
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Sections d4.Udi, d4.Serial number, and h4.Device manufacture date completed as review of manufacturing and inspection records has been completed.The device was not returned for evaluation.No issues were reported with the device itself.The device history record (dhr) was reviewed for lot 1095854.All inspections passed and no issues were identified in the dhr review.A two year review (november 2020 - october 2022) of the complaint database found two(2) complaints for the extremilock trays and modules.One of the complaints is the complaint addressed in this report.The other complaint is addressed in report number 2027754-2022-00053.The same tray, serial number 215efs, was used in both cases.Review of the instructions for use (ifu) revealed the "sterility" section of the ifu outlines the recommendations for autoclaving the extremilock trays.The ifu states "osteomed recommends using aesculap rigid containers and paper filters.The extremilock foot plating system (e-fps) contents need to be split and loaded into 2 aesculap extra-long rigid containers.The large tray insert from the upper level needs to be loaded into an aesculap extra-long basket, p/n jf232r, and then the basket is lowered into an extra-long rigid container, p/n jn445/jk490 (bottom/lid).The remaining components from the e-fps shipping container, the 4 upper modules and the 5 lower modules, are to be loaded into another extra-long basket, p/n jf232r, and then loaded into the second aesculap extra-long rigid container, p/n jn445/jk490 (bottom/lid).Modules 320-2906 and 320-2904 need to be stacked on top of each other".This information was relayed to the field who reported they would communicate this with the facility as the facility does have aesculap containers.Based on the information received and the investigation performed, the root cause of the hole in the blue wrap could not be determined.
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