Model Number 2178-63-136 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
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 attachment end of 10mm reamer is burred so it gets stuck on modified hudson adapter.Modified hudson adapter is stripped therefore the reamers will not work properly when attached to the power.The connecting end of the fem adapter torque wrench is worn and will not hold fem adapter firmly in place when applying torque.Please send replacements p1 to trident attn: or/jason ozment.
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Manufacturer Narrative
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Product complaint # : (b)(4) investigation summary : device was returned for examination.Evidence of usage can be seen, the post part connecting to the sig fem adpt torque wrench shows some damage confirming the allegation, however we weren't able to functional test the attachment capability with the sig fem adpt torque wrench because that device was not provided.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 : 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.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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Search Alerts/Recalls
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