WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: RAFN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Malunion of Bone (4529); Unspecified Musculoskeletal problem (4535)
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Event Type
Injury
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Manufacturer Narrative
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Additional narrative: 510k: this report is for an unknown rafn nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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) 2021 the patient presented with a fracture of the left distal femur and was operated on (b)(6) 2021 for fixation using the retrograde/antegrade femoral nail (rafn) system.On (b)(6) 2021, during routine follow up the x-ray had demonstrated loosening of the distal transverse screw consistent with patient complaining of local sensitivity.The surgeon removed the loose screw under local anesthesia.The surgeon continued normal follow-up course for the patient.On (b)(6) 2022, at routine follow-up, the x-ray showed signs of varus collapse.The surgeon stated the patient¿s bone is healed and that the patient is ambulatory.As of (b)(6) 2022, the surgeon does not plan to revise this patient.This complaint captures the reported post-op event of signs of varus collapse, while related complaint (b)(4) captures the reported postop event of loosening of the distal transverse screw.This report is for one (1) unk - nails: rafn.This is report 2 of 4 for complaint (b)(4).
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Manufacturer Narrative
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This report is for an unknown rafn nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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) 2021 the patient presented with a fracture of the left distal femur and was operated on (b)(6) 2021 for fixation using the retrograde/antegrade femoral nail (rafn) system.On (b)(6) 2021, during routine follow up the x-ray had demonstrated loosening of the distal transverse screw consistent with patient complaining of local sensitivity.The surgeon removed the loose screw under local anesthesia.The surgeon continued normal follow-up course for the patient.On (b)(6) 2022, at routine follow-up, the x-ray showed signs of varus collapse.The surgeon stated the patient¿s bone is healed and that the patient is ambulatory.As of (b)(6) 2022, the surgeon does not plan to revise this patient.This complaint captures the reported post-op event of signs of varus collapse, while related complaint (b)(4) captures the reported postop event of loosening of the distal transverse screw.This report is for one (1) unk - nails: rafn.This is report 2 of 4 for complaint (b)(4).
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Search Alerts/Recalls
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