Model Number 2217-50-041 |
Device Problems
Loose or Intermittent Connection (1371); Device Slipped (1584); Material Twisted/Bent (2981); Unintended Movement (3026)
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Patient Problem
Not Applicable (3189)
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Event Date 11/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device was reviewed by depuy engineering (b)(4) in (b)(4) which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The device was reviewed by depuy engineering (b)(4) in (b)(4) which states: i have assessed this instrument complaint.As can be seen from the attached photographs there is some heavy impaction damage to the handle/shaft and impacting head.Also noted was that there is some movement between the impacting head and handle.I am unable to ascertain the approx.Year of manufacture from the lot i/d nb343372.My assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.The device was manufactured in may 2013.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.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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Total hip replacement: (b)(6) 2019.Surgeon commented when impacting cup that the handle was moving around when it should be fixed.10 minutes delay.No ae reported.
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Manufacturer Narrative
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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. h10 additional narrative: corrected: h6 (device).Product complaint # (b)(4).Investigation summary : the device was reviewed by depuy engineering melbourne in a-3423497 which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.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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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.Product complaint # : (b)(4).Investigation summary : the device was reviewed by depuy engineering melbourne in (b)(4) which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.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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Search Alerts/Recalls
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