STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA TIBIA 12X255MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 2341-1225S |
Device Problem
Positioning Failure (1158)
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Patient Problem
Limb Fracture (4518)
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Event Date 11/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
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Event Description
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As reported: oblique fracture of the distal 1/3 of the tibia.Perform flexible reaming up to f13 and insert f12 × 255 mm nails.At the time of nail insertion, the central bone fragment was displaced anteriorly at the fractured part, so a blocking k wire was inserted, but after repositioning, it was inserted again, but anterior dislocation again.The posterior part of the fracture was greatly crushed, and the doctor decided that the t2 alpha tibial nail could not maintain the reduction position, so it was changed to external fixation.Doctor's comment: the shape of the nail did not match the shape of the patient's bone.The bone quality was too weak.The plate will be fixed at a later date.
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Manufacturer Narrative
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The alleged event was not confirmed.Product and / or medical records were not provided.A review of dhr, nc history, labelling and rmf revealed no deficiency.According to documentation the item was distributed according to specs.The labelling provides information how to determine the nail size.According to received information (¿the shape of the nail did not match the shape of the patient's bone.The bone quality was too weak¿) the alleged event was classified having been caused by a suboptimal implant selection and was regarded being user related.In case other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a new root cause.With available information a deficiency of the device could not be verified.
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Event Description
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As reported: oblique fracture of the distal 1/3 of the tibia.Perform flexible reaming up to f13 and insert f12 × 255 mm nails.At the time of nail insertion, the central bone fragment was displaced anteriorly at the fractured part, so a blocking k wire was inserted, but after repositioning, it was inserted again, but anterior dislocation again.The posterior part of the fracture was greatly crushed, and the doctor decided that the t2 alpha tibial nail could not maintain the reduction position, so it was changed to external fixation.Doctor's comment: the shape of the nail did not match the shape of the patient's bone.The bone quality was too weak.The plate will be fixed at a later date.
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