Model Number 2217-50-041 |
Device Problems
Device-Device Incompatibility (2919); Naturally Worn (2988); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).1.Please clarify what do you mean in the event description that state "handle piece is rotating"? is it break, bent, cracked, stripped, scratched, worn, cross threaded or any device interaction? please see image 2.Please provide the lot number of the pinn straight cup impactor (221750041).Lot # was not obtainable due to all codes being worn off the instrument.3.Can you please provide the date of event? (b)(6) 2023.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 handle piece is rotating.
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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 confirmed the complaint.The gray handle is very loose and spins freely.Additionally, device presents an overall worn condition.It is reasonable to conclude that the device is not able to hold mating devices properly.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Reviewed photo of pinn straight cup impactor reveals device has no issues identified.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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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: added: d4 (lot), d9, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Search Alerts/Recalls
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