Model Number 2544-00-522 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2021 |
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 while using the distal femoral cutting block, the pin got caught in the pin hole and would not come out.After removing the pin, it seemed that the hole may have a burr in it which is catching the pin.I would guess that the block has been used in over 200 surgeries.Also, the scrub noticed that two of the femoral impactors were showing signs of wear.One has a crack at the point where the handle attaches.The other is scuffed on the end that impacts the femur.I¿m sure that both impactors have been used in 50 plus surgeries.
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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 for analysis.Examination of the returned device confirmed the reported event.Burr was detected on 2 of the 8 pin holes.The noted damage is consistent with device wear out due to normal intended use and the investigation did not establish a need for corrective action.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3.
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Search Alerts/Recalls
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