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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 an unknown date that the trocar handle no longer retains sleeve drill bit dull.Guide pin no longer smooth.It was unknown if there was a surgical delay.The procedure and fragments outcome were unknown.There was no patient consequence.Concomitant devices reported: unknown guides/sleeves/aiming: sleeve (part# unknown, lot# unknown, quantity#1).This is report 2 of 3 (b)(4).
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Product complaint # (b)(4).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.H10 additional narrative: h3, h6: investigation summary background: trocar handle no longer retains sleeve, drill bit dull, guide pin no longer smooth.Concomitant devices reported: unknown guides/sleeves/aiming: sleeve (part# unknown, lot# unknown, quantity#1).This complaint involves three (3) devices.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images provided in the attachments "_external_ re_ (b)(4).The image was reviewed, and the complaint condition could not be confirmed because the defect can not be identified from the provided image.Since the device was not returned, dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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