Model Number 58802718 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Implant Pain (4561)
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Event Date 01/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion( right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.
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Manufacturer Narrative
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The reported event could be confirmed based on the operative report of the revision surgery.The device inspection revealed the following: a total of eight (8) devices were returned for evaluation.The devices consisted of one (1) broken plate and seven (7) screws.The broken plate and three (3) of the screws were determined to belong to the variax 2 system.The evaluation of the broken plate and the three (3) screws were performed under complaint pi (b)(4).Visual examination of the other four (4) screws revealed the screws are characteristic of legacy wright medical cannulated screw system (css).Microscopic view of the returned device confirms the lot number and size.The screw head shows signs of wear.No other significant damages are visible on the device.Aside from the signs of wear, the screw is in good condition and there is no indication that the screw contributed to the reported non-union.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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Event Description
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It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion (right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.
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Search Alerts/Recalls
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