The device has not been returned.However, the device investigation has been completed and the results are as follows: dhr results lot information not provided - dhr could not be reviewed.Stock product reviewed results lot information not provided - stock product could not be reviewed.Investigation methods/results attempts to retrieve the device or determine the status of the device have been made but to no avail.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.It is unknown how the customer stored and handled the surgical kit.Additionally, it is unknown if the customer followed the cleaning protocols as listed in user manual 6539 rev.4.0 (hahn tapered implant guided surgery manual).Per user manual 6539 rev.4.0 (hahn tapered implant guided surgery manual), the instrumentation section notes: "all instruments should be cleaned, disinfected, and sterilized according to a validated method prior to use in the oral environment.· cleaning: wash using a broad-spectrum cleaning solution, followed by thorough rinsing and drying.The recommended disinfection process is based on ansi/aami st79 guidelines, as follows: · disinfection: immerse in disinfectant,1 rinse with distilled water, and dry.The recommended sterilization process is based on the ansi/aami/iso 17665-1 and ansi/aami st79 guidelines, as follows: · sterilization: gravity-fed sterilizers: autoclave in sterilization pouch for 15 minutes at 132° c (270° f).Allow sterilized components to dry for at least 30 minutes." additionally, user manual 6539 rev.4.0 (hahn tapered implant guided surgery manual) list the following in the general cleaning information section: · observe universal precautions for the handling of contaminated or biohazardous materials.· clean promptly after each use, to prevent biological fluids and tissues from drying on the instruments.· when applicable, disassemble parts and instruments prior to cleaning.· do not rely solely on automatic cleaning.Thorough manual cleaning is recommended.· preliminary cleaning should consist of wiping parts, soaking them in a lukewarm enzymatic solution for a minimum of twenty (20) minutes and rinsing them with running water.· routine cleaning should consist of (a) washing parts using a broad-spectrum cleaning solution, followed by thorough rinsing and drying; and (b) sonicating parts fully submerged in cleaning solution for at least ten (10) minutes, preferably at 45-50 khz, followed by thorough rinsing and drying.· dry promptly and completely to avoid oxidation.
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