Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00249004732, threaded pin 3.2 mm diameter 508 mm length, 63945303.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03262.
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Event Description
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It was reported that 3.2 mm guide wire tips from guide wires broke off inside the patient twice when positioning the guide wire for the lag screw.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that 3.2mm guide wire tips from guide wires broke off inside the patient twice when positioning the guide wire for the lag screw.The wire tip fragments were left in situ and it is unknown if these will be explanted at a later date.No further patient consequences have been reported.Attempts have been made and additional information on the reported event is unavailable.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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The x-rays provided were sent to hcp for review.Their review confirmed the presence of foreign bodies in the patient's femur.However, the precise location of the pieces cannot be determined on these fluoroscopic images.The more proximal piece, seen on all three views, appears to be external to the femoral head and there is insufficient visualization to determine bone quality complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device confirmed fracture near the threads and the threaded portion was not returned.Also noted heavy galling on the shafts.The device shows heavy wear marks through the etched lot number obscuring a digit.Lot number could not be determined.Dimensions taken are within specification.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined. if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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