WRIGHT MEDICAL TECHNOLOGY INC FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS #2S; PROSTHESIS, TOE, CONSTRAINED, POLYMER
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Model Number G4260102 |
Device Problem
Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the swanson implant box was opened, two proximal grommets in package.
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Manufacturer Narrative
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Correction d9/h3, h6 method code; the reported event could be confirmed, since the device was returned with the proximal grommet missing and two distal grommets found instead in the packaging.Based on investigation, the root cause was attributed to a manufacturing related issue.The failure was caused by improper handling/packaging of device.The current instructions for use states: "the swanson flexible hinge toe joint grommet is a thin titanium shield designed for use with the swanson flexible hinge toe implant in rheumatoid patients where cutting or abrasion of the flexible implant from contact with thin, sharp bone edges can occur, or in patients who have high activity levels.It is contoured to conform to the shape of the midsection of the flexible implant and is fabricated from unalloyed titanium for surgical application.The distal grommet is used on the distal stem and the proximal grommet is used on the proximal stem to protect the implant from biomechanical shearing forces of sharp bone edges during joint motion." a nonconformance was opened into this issue to further investigate the problem.
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Event Description
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It was reported that the swanson implant box was opened, two proximal grommets in package.
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Search Alerts/Recalls
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