WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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Model Number 02.124.414 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/25/2020 |
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 on (b)(6) 2020 during an open reduction internal fixation (orif) of a distal femur fracture the 4.5mm variable angle locking compression plate condylar system was used.During the operation the connecting bolt for the percutaneous outrigger failed to attach to the 4.5mm variable angle locking compression plate curved condylar plate/14 hole/301mm/right.There were no issues with attachment to any other length plate in the system and a second instrument set opened during the case produced the same result.The 14 hole plate was used without the outrigger, causing minimal delay, but greatly increasing surgical difficulty.Additionally, the handle for percutaneous threaded drill guides would properly attach to the drill guides.This was remedied with minimal delay through the use of the second instrument set.There was a surgical delay of twenty (20) minutes.Procedure was successfully completed.There is no patient consequence reported.This report is for one (1) 4.5mm va-lcp curved condylar plate/14 hole/301mm/right.This is report 1 of 4 for (b)(4).
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