WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: 4.0 MM CANNULATED; SCREW,FIXATION,BONE
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Device Problem
Device Slipped (1584)
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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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This report is for an unknown 4.0 mm cannulated screw.Part and lot numbers are unknown; udi 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 (b)(6) 2019, the patient underwent a revision procedure due to screw loosening.Initially, the patient had the primary procedure 6 months ago.Surgeon noticed loosened screw on x-ray.During the revision procedure, one 3.5 cortex screw and two 4.0 cannulated screws were successfully removed while the lateral distal fibula plate and a screw were left in the patient.The procedure was successfully completed without any surgical delay.Patient status was unknown.No fragments were generated.Concomitant device reported: unknown distal fibula plate (part # unknown, lot # unknown, quantity unknown).This complaint involves three (3) devices.This report is for one (1) unknown 4.0 mm cannulated screw.This is report 3 of 3 for (b)(4).
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Search Alerts/Recalls
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