Zimmerbiomet complaint number (b)(4).One tsv instrument kit comple (tsvkit) was returned for investigation.Visual inspection of the as returned product identified minor signs of use and oxidation/rust on some of the components.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Appropriate documentation was reviewed and the following information was identified: documents reviewed: instructions for use for zimmer® instrument kit system and driva¿ drills 8874 rev 4-07/14 information identified: precautions product packaging cleaning/sterilization information.It was reported that when the customer opened the kit (tsvkit) drills had corrosion on them.He was unable to complete the surgery.The patient was in the chair with the surgical flap opened.He noticed the corrosion on the tap drill and had to close the site back up and send the patient home.The reported complaint was confirmed during visual inspection.A definitive root cause for this complaint could not be determined.The following sections have been updated: date of this report.Expiration date, udi: (b)(4).Date received by manufacturer.Type of report, follow-up number.Follow up type.Device evaluated by manufacturer: change ¿no' to 'yes'.Device manufacture date.Evaluation codes.Additional narrative.The following sections have been corrected: h5: labeled for single use.
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