Occupation: synthes employee.510k: this report is for an unk - drill bits/unknown lot.Part and lot numbers are unknown; udi number is unknown.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, which was a day before surgery, the hospital found that unknown cannulated driver and unknown cannulated drill bit were stained with blood and tissue.The hospital washed and sterilized them, and they were used in the surgery.No patient involvement.This report is for 2 of 3 for (b)(4).
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