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Catalog Number UNK-ATTACHMENTS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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Of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported that during an unspecified surgical procedure, while using the kincise power broach system, the "fem" was fractured during sequential broaching.It was further reported that the fracture occurred at the distal tip of the #6 broach.It was reported that the broach was removed and a long stem was implanted.It was reported that there was a 45 minute delay in the surgical procedure.It was not reported whether a spare device was available for use.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Corrected data: the is adverse event field was inadvertently left unchecked in the initial medwatch.The field has been updated to reflect an adverse event.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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Manufacturer Narrative
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Additional information: upon subsequent follow-up with the reporter, additional information was received.Following patient information was received and applicable fields have been updated in the medwatch.Patient initials: (b)(6), age: (b)(6), gender: female.It was reported that the while sequentially broaching the femur, a femoral fracture occurred when the #6 broach was put down the femur.The broach was removed intact.It further reported that it was the bone that fractured, not the associated device.The procedure was completed successfully using a long stem device.It was reported that event occurred during a total hip replacement surgical procedure.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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