Catalog Number N55 |
Device Problem
Device Difficult to Maintain (3134)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k: unknown.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary - the investigation could not be completed; no conclusion could be drawn.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 on an unknown date, during regular cleaning of the tfn helical blade insertion handle it was noticed that the n55 was unable to be taken off from the handle and therefore the insertion handle/helical blade inserter was not able to disassemble properly.There was no patient involvement.Concomitant device reported: unknown tfn helical blade (part # unknown, lot # unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) replacement alignment indicator for 357.372.This report is for 1 of 2 for (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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