SMITH & NEPHEW, INC. VIS ADPT GUIDE KIT JII; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number V0100112 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that during tka surgery, the tibial block of a vis adpt guide kit jii did not fit well at all.There was a large amount of space between the anterior tibia and the tibial visionaire block.Also, standard instrumentation was used on the tibia, because surgeons did not trust the block with it fitting so poorly.Surgery was resumed after a non-significant delay with a s+n back-up device.Patient was not harmed as consequence of the problem.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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