WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: TFN; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Reaction (2414); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional patient identifier reported as 6157273.This report is for an unknown tfn end caps/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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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Event Description
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It was reported that on an unknown date the patient will undergo the trochanteric fixation nail (tfn) removal procedure due to a draining sinus track.Surgeon stated patient was healed.Procedure and patient outcome are unknown.No further information provided.Concomitant devices reported: tfn helical blade (part # unknown, lot # unknown, quantity 1); tfn nail (part # unknown, lot # unknown, quantity 1); locking screws (part # unknown, lot # unknown, quantity unknown).This report is for unknown quantity of unknown tfn end caps.This is report 4 of 4 for complaint (b)(4).
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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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