Model Number 1035-46-000 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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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Surgeon is complaining the fit between the inlay and the metal shell in the selfcentering bipolar head.A larger clearance of the components than in the past was observed and clarification was requested.Another selfcentering bipolar head was available and used (same ref, other lot), but the phenomenon was the same here.Surgery was finished anyhow, an adverse patient consequence was not reported, a surgical delay was not 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.
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Event Description
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Additional information received that the event occured during primary surgery.Material received at loc but shipment to analysis site delayed due to quarantine restrictions.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: review of manufacturing records was performed by depuy and found all products in this lot passed inspection prior to release from manufacture according to the dhr.H10 additional narrative: added: e1.
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Search Alerts/Recalls
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