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.Device available for evaluation:complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Postal code (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 united kingdom as follows: it was reported on an unknown date that on doing a couple of cases, the measure guide for the large fragment kits were broken.We end up getting wrong measures of the screws which end up delaying our operation quite a bit and also wasting a few implants.They are the large frag depth gauge, this kits have been there for ages.No further information is available.This report is for one (1) depth gauge f/scr ø4.5-6.5 meas-range up this is report 1 of 1 for complaint (b)(4).
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