Model Number RS22 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Events reported in mwr-2210968-2020-10262., 2210968-2020-10263, 2210968-2020-10264.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that a patient underwent an orthopedic procedure on 11/30/2020 and a suture was used.During the procedure, the suture pulled off the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint#: (b)(4).Were there any adverse patient consequences reported? unobtainable.Once there is any update, we will update the information.
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Manufacturer Narrative
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(b)(4).Date sent to the fda: 1/20/2021.H6 component code: g07002 device not returned.A manufacturing record evaluation was performed for the finished device batch qbbjje, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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