Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 during a tarso-metatarsal joint (tmtj) fusion of the left foot procedure on (b)(6) 2019, a 2.0mm drill bit from variable angle forefoot/midfoot set broke off in patient due to the use of excessive force of the surgeon while drilling into the bone of the patient.The broken piece was retrieved, and the drill bit was discarded.The procedure was completed without surgical delay and patient consequences.This report is for one (1) 2.0mm drill bit w/depth mark.This is report 1 of 1 for complaint (b)(4).
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