Model Number 6704-0-520 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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During a primary surgery, 2 separate dall miles cables with different lot codes broke during surgery.Surgical delay 1min, surgery completed successfully.Photos and device not available.No further information available due to hospital policy.
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Manufacturer Narrative
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Updated the lot number, manufacturing and expiration date.Reported event: an event regarding crack/fracture involving a dall miles cables was reported.The event was not confirmed.Method & results: device evaluation and results: not performed because product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been no other events for the reported lot.Conclusion: it was reported that the patient had a surgical delay due to crack/fracture involving a dall miles cables.The exact cause of the event could not be determined because no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
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Event Description
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During a primary surgery, 2 separate dall miles cables with different lot codes broke during surgery.Surgical delay 1min, surgery completed successfully.Photos and device not available.No further information available due to hospital policy.
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Search Alerts/Recalls
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