Model Number 2010-07-100 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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 threaded rod is missing on the device and should be code for missing components.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned instrument cannot confirm the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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.H10 additional narrative: added: d9 corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and visual : missing components were reviewed.It was determined visual : missing components has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 12 2022.In total, there have been zero serious injuries and zero deaths reports related to visual : missing components in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, visual : missing components associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.D2b(procode).
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Search Alerts/Recalls
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