Catalog Number 201001030 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Not Applicable (3189)
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Event Date 05/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4)."iff information s obwatch, a folsow-u medwatch will be filed as appropriate.Llow-up medwatch will be filed as appropriate.".
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Event Description
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It was reported that the broach connector piece was broke off while impaction.This is the second time at this account and the surgeon wants it to be investigated.There is no way to remove a broach when this piece is broken.This is a patient safety issue and needs to be addressed.There was 5 minutes surgical delay.
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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.Product complaint # (b)(4).The device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information 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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Additional information received indicating that it was confirmed that the broken piece of the broach was removed from the patient.
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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.Added: b5 corrected: h6 (device code) the previous device code (embedded device) is being retracted as it was further identified that the broken piece of the broach was removed from the patient.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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Search Alerts/Recalls
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