Model Number 2611-30-000 |
Device Problems
Break (1069); Crack (1135); Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2022 |
Event Type
malfunction
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Event Description
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On (b)(6) 2022 the spd department at (b)(6) denied the delivery of six trays.The hospital staff observed damage on the brackets which hold the instruments in place within the graphic cases as well as the general condition of the plastic tray inserts.This issue was identified on (b)(6) and replacement trays were delivered on june 6th for the case that was scheduled on (b)(6).Consultant confirmed that there was no impact or delay in surgical schedule due to this event.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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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).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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Event Description
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Additional information received.Indicated that, some of the plastic inserts had holes and discoloration, due to what appeared to be some sort of ink transference.As well as the epoxy coating on the metal pieces, that protrude from the tray inserts to hold the instruments in place was cracked/peeling and pulling apart or had completely broken off.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary - the device associated with this report was returned for analysis.Visual inspection found the device had a few metal inserts coting peeling.Additional findings were few rubber base components broken and tray component had cracks visible.The reported condition was confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The device's top was not returned.Device history lot - a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.Corrected: h3.
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Search Alerts/Recalls
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