Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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 canada as follows: it was reported on (b)(6) 2023, that the surgeon reported that the drill bit was binding inside the protection sleeve while preparing for a spiral blade while using the retrograde/antegrade femoral nail instruments.The positive stop feature between the sleeve and drill bit was worn, causing the drill bit to pass too deep into the sleeve and causing the bit to bind within the sleeve.As a result of the binding, the drill bit and sleeve became hot, resulting in a minor thermal injury to the patient¿s skin.The instruments were removed from the set and discarded.The instruments require replacement.There were patient outcomes and consequences.There was a thermal injury to the patient's skin.This report is for one (1) protect sleeve 15/13 f/spir blade lock y.This is report 2 of 2 for complaint (b)(4).
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