WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY
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Model Number 04.005.418 |
Device Problem
Migration (4003)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional product code: hwc synthes sales representative.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2018, the patient underwent a removal/revision of damaged titanium locking screws in the tibia nail on an unknown date.It was further reported, the titanium locking screw may have migrated and was removed and replaced with a longer screw.The unknown locking screw was broken and a piece was retained, another screw was placed.It is unknown if there was surgical delay.Patient outcome is unknown.Procedure was successfully completed.Concomitant device reported: unknown tibial nail (part# unknown, lot# unknown, quantity# 1).This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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Reporter is a synthes employee.Additional information provided.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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