Model Number 1363-43-000 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that the implant was contaminated with a sticker and also looks like it was repackaged.Surgical delay of 3 minutes occurred.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: right hip.
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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 device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device and photo evidence provided found no evidence of a device non-conformance.The sterile packaging was found unsealed, and the peeling tab, that is normally present on the polymer plastic sheet, was found twisted and stuck to the actual implant, instead of the polymer sheet.However, with the information provided, it is not possible to determine the moment where the sticker got attached to the implant.The reported foreign matter found inside sterile packaging condition was confirmed.However, sterility compromised condition was not able to be confirmed with the information provided.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4) pcs.2) date of manufacture: 28-feb-2020.3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities were identified.4) expiry date: 31-jan-2030 5) ifu reference: ifu-0902-00-701.Device history review = > 1) quantity manufactured: (b)(4) pcs.2) date of manufacture: 28-feb-2020.3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities were identified.4) expiry date: 31-jan-2030 5) ifu reference: ifu-0902-00-701.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device and photo evidence provided found no evidence of a device non-conformance.The sterile packaging was found unsealed, and the peeling tab, that is normally present on the polymer plastic sheet, was found twisted and stuck to the actual implant, instead of the polymer sheet.However, with the information provided, it is not possible to determine the moment where the sticker got attached to the implant.The reported foreign matter found inside sterile packaging condition was confirmed.However, sterility compromised condition was not able to be confirmed with the information provided.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 28-feb-2020.3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities were identified.4) expiry date: 31-jan-2030 5) ifu reference: ifu-0902-00-701.
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Search Alerts/Recalls
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