TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Catalog Number ARS655101 |
Device Problem
Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2023 |
Event Type
malfunction
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Event Description
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The end user reported that the 0mm assembly screw was too short and couldn't be use to attach the proximal and distal body of the revive humeral prosthesis to each other.
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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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Manufacturer Narrative
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The reported event could not be confirmed.The device has not been returned and no other evidence has been provided for investigation.A device inspection was not possible since the affected device was not returned, and no other evidence has been provided.A review of the labeling and device history for the reported lot did not indicate any abnormalities.No indications of material or design related problems were found during the investigation.This event has been escalated to a capa within our quality system for further investigation.Based on the investigation, the root cause was attributed to a manufacturing related issue.It was discovered that ars655118 lot az1822082 (b)(4) and ars655101 lot az1322077 (b)(4) were processed through packaging at the same time.The supplier stated they believe this is a complete swap of lots.They have opened a capa on their end to formalize the root cause and escape.If any additional information is provided, the investigation will be reassessed.
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Event Description
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The end user reported that the 0mm assembly screw was too short and couldn't be use to attach the proximal and distal body of the revive humeral prosthesis to each other.
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Search Alerts/Recalls
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