Model Number 2570-04-500 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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Calcar planer was binding on the #6 actis broach.No surgical delay.No adverse affects on the patient.
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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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Event Description
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Additional information received.Indicated, that the instruments were binding, rubbing together with friction.
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Manufacturer Narrative
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Product complaint #: pc-(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: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h1 and h6 (clinical and impact codes).
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Event Description
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Additional information received indicated that the calcar planer locked onto the shaft of the actis broach and spun the broach fracturing the proximal femur.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this complaint was returned for examination.The visual examination of the device found no device jammed.The reported condition was not confirmed.No issue was found on the device.Depuy considers the investigation closed.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.
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Search Alerts/Recalls
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