Model Number 2307-84-000 |
Device Problems
Device-Device Incompatibility (2919); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that the surgeon utilising delta xtend 145 epiphysis instruments.After placing the trail stem on the 145 rsa implant inserter and impacting the trial into the humerus, the surgeon stated he had difficulty in disengaging the handle from the trial.Surgeon states he feels the impactor handle is 'too stiff and not easy to disengage from the trial.' handle was successfully disengaged after several attempts and surgery proceeded as normal.
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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).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found, nothing related to a device non-conformance that would denote a stiffness/jammed condition of the lever mechanism, nor inability to disassemble.Functional test found lever is able to move freely.The reported condition could not be 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 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 manufacturing records evaluation mre was not performed.
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Search Alerts/Recalls
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