Model Number 2128-62-110 |
Device Problems
Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2023 |
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 pin jammed in the guide.
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Manufacturer Narrative
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(b)(4).Investigation summary = > per the event description, this complaint (pc-001357362) is capturing the delivery service issue for the cutting guide being shipped back to the customer after the customer had previous reported a product issue with the device.The device was previously reported on (b)(6) for the same product issue observed again later by the customer in (b)(6) the investigation of the product malfunction is captured under (b)(6) the delivery service issue was escalated as a quality issue (qi) by the loaner site.Device history lot = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.
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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 : per the event description, this complaint ((b)(4)) is capturing the delivery service issue for the cutting guide being shipped back to the customer after the customer had previous reported a product issue with the device.The device was previously reported on (b)(4) for the same product issue observed again later by the customer in (b)(4)).The investigation of the product malfunction is captured under (b)(4).The delivery service issue was escalated as a quality issue (qi) by the loaner site.
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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.H10 additional narrative: 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 there was no surgical delay.The procedure completed.One pin was used instead of two and the cut was completed.
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Search Alerts/Recalls
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