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Model Number 7205519 |
Device Problems
Failure to Align (2522); Material Twisted/Bent (2981)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that during the set up before the surgery, it was noticed an inaccuracy of the tibia tip aimer, 4-point bullet and acufex tibia tip aimer have been all set up, 2.4mm guide pin was used and it was noticed that the exit of the guide did not hit the tip of the aimer, it slightly deviated to the tip.No patient injuries or delay reported.Smith and nephew back-up device was used to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H11: corrected information in h6 (health effect - impact code).
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Manufacturer Narrative
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H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows light wear from use, the laser etchings are legible.There are no deformities visible.A functional assessment of the device found it functions as designed with reference devices.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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