STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 0227-6080 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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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 by the customer that: "when doing a tibial nail the reamer metal started to unravel while it was in the patients tibia.Surgeon able to slap it out with no apparent harm to the patient.".
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Event Description
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It was reported by the customer that: "when doing a tibial nail the reamer metal started to unravel while it was in the patients tibia.Surgeon able to slap it out with no apparent harm to the patient.".
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Manufacturer Narrative
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Correction - d3 (manufacturer entity), d9/h3, h3 (reason for no evaluation).The reported event could be confirmed, since one received image showed unraveled outer and inner spirals; at least the outer spiral was additionally broken off from the counterpart.The spiral was uncoiled in counterclockwise direction.Areas with reamer head resp with adapter connection were not shown.Spirals opened in counterclockwise direction had been operated in left-hand direction.The labeling prohibits turning to the left.If additional, substantive information or the item is provided the record will be reopened and the investigation will be re-assessed.The root cause was attributed as a user related issue.H3 other text : device disposition unknown.
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