WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/42MM; SCREW, FIXATION, BONE
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Model Number 214.542 |
Device Problem
Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/18/2019 |
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.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 during an open reduction internal fixation (orif) of the tibial tubercle on (b)(6) 2019, the 4.5 cannulated screw was placed into the patient and the thread came off.The surgeon stated that he believed the thread came off due to extremely hard bone and that he did not pre drill.During screw insertion the thread of the screw unwound off the core of the screw.No attempts were made to retrieve the fragment.Device was left in the patient.Procedure was successfully completed with no surgical delay.Patient outcome was good.Concomitant devices: plate (part: unknown, lot: unknown, quantity: 1).This report is for a 4.5mm cannulated screw.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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