Model Number 2545-01-703 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that the customer is complaining the att-containers as container´s plastic coating is loosening.
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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 # = > pc-(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.H3.
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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 examination of the device and the provided photographic evidence confirm the reported allegation.The device presents a condition of constant and heavy usage, with the nylon coating peeling off.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was retrieved for this device.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.Photo evidence provided was reviewed and found the case peeling.The reported condition was confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the 7033 is not a valid finished goods lot number; therefore, a manufacturing records evaluation (mr e) was not performed.
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Search Alerts/Recalls
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