WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 456.302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); No Code Available (3191)
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Event Date 02/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.(b)(4).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 (b)(6) 2020, the surgeon removed a trochanteric fixation nail (tfn) because the patient had arthritis.The tfn nail, titanium (ti) helical blade, titanium (ti) locking screw and end cap were removed with no issues.There was no surgical delay.Procedure successfully completed.No patient consequence.This complaint involves four (4) devices.This is 2 of 4 for report (b)(4).
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Search Alerts/Recalls
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