WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 456.322S |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that on an unknown date, the tfna nail did not assemble properly.The surgeon used another nail to complete the procedure.No surgical delay reported.It is unknown if the procedure successfully completed.No patient consequence reported.This report is for one (1) 12mm/130 deg ti cann troch fixation nail 170mm-sterile this is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: initial reporter is synthes sales representative.This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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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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.H10 additional narrative: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot = > part #: 456.322s.Synthes lot #: h469687.Supplier lot #: n/a.Release to warehouse date: 09 oct 2017.Expiration date: 31 aug 2026.Manufactured by: monument.Supplier: n/a.No ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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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