Model Number 2522-26-003 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 08/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The primary surgery was performed on (b)(6) 2020 via tha.Before the surgery, the hospital staff sterilized the devices by cleaning and drying with a machine.It was reported that after sterilization, the staff set out the devices for the surgery, and he/she found that water remained in the 9 trial heads when he/she pulled out the devices from the case.He/she had checked that there was no water in the trial heads when set them in the drying machine.The staff judged poor sterilization because water was remained in the devices despite sterilized by autoclave, and he/she sterilized the devices again.Preventing a recurrence of water¿s remaining, the trial heads were sterilized into small groups.The remaining of water was found at the last minute of the surgery, but barely made using in the surgery.The surgery was completed without any surgical delay.There was no harm to the patient.
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Manufacturer Narrative
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Product complaint # (b)(4).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 depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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