Model Number 1504-11-125 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); 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 12/07/2022 |
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 outer packaging was damaged.
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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 indicates that there was no patient consequence.
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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 product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to depuy cork which conducted a visual inspection of the returned device.On examination of the returned complaint unit, it was observed that there was a cut/tear in the outer blister, the sterile of the unit was compromised by the damage observed.However the current complaint condition cannot be attributed to a manufacturing issue.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) parts were manufactured to specification.2) date of manufacture: 9/28/2021.3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.3 parts from this lot were scrapped and were not distributed.4) expiry date: 8/31/2031 5) ifu reference: ifu-0902-00-870.Device history review : 1) quantity manufactured: (b)(4) parts were manufactured to specification.2) date of manufacture: 9/28/2021 3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.(b)(4) parts from this lot were scrapped and were not distributed.4) expiry date: 8/31/2031 5) ifu reference: ifu-0902-00-870.
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Search Alerts/Recalls
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