Model Number 1320-0111 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
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Event Description
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It was reported: "the surgery was almost complete when the aiming device was to be removed, it was not detachable.The aiming device cannot be removed from the long gamma nail.There was a quasi cold connection between the implant and the insertion aid.Consequence: removal of the already fully implanted nail incl.Femoral neck screw and distal locking and re-implantation of a new nail.The procedure was delayed by 1h which lead to higher blood loss.".
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Event Description
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It was reported: "the surgery was almost complete when the aiming device was to be removed, it was not detachable.The aiming device cannot be removed from the long gamma nail.There was a quasi cold connection between the implant and the insertion aid.Consequence: removal of the already fully implanted nail incl.Femoral neck screw and distal locking and re-implantation of a new nail.The procedure was delayed by 1h which lead to higher blood loss.".
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Manufacturer Narrative
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Please note the correction to d9/h3 as the device was returned for evaluation.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the returned devices were received in a disassembled state.Proximal hole of targeting shows signs of damage along with damaged body indicating extensive usage.Upon closed look remnants/stains of dried blood were found in the screw insertion hole of targeting arm suggesting that blood percolated in assembly.The percolated blood in targeting arm most likely caused cold welding resulting in jamming of the devices making it difficult to disassemble post decontamination, pre-surgical test was conducted for the returned devices.Upon inspection, the devices were functionally ok.While inserting the nail holding screw in the target device slight resistance could be felt but parts could be assembled a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is most likely user related.The percolated blood in targeting arm most likely caused cold welding resulting in jamming of the devices making it difficult to disassemble if the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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