EXACTECH, INC. THREE PEG PATELLA 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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Model Number THREE PEG PATELLA 32MM |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the investigation conducted regarding complaints of hair in sterile packaging, inconsistencies in prevention methods were found such as use of ppe at handling and detection methods, such as standard inspection process for identifying the existing visual inspection criteria.No environmental control was found to ensure lighting is consistent at inspection points and review of training records show there is no standard method to document confirmation of operator ability to detect this particular defect.Additionally, the risk of foreign particulate or hair in the package was not identified in the fmea.Although reported to have been noticed upon opening of the inner packaging, the complaint device was returned without intact sterile packaging so the presence of the hair inside the packaging prior to opening the implant cannot be confirmed.Based on our internal investigation, the hair within sterile packaging reported was likely the result of a lack of standardization around variables (process, lighting, ppe) pertaining to material handling and visual inspection.A risk assessment has been initiated to escalate this issue.
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Event Description
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As reported, prior to use/during set-up product was opened, and it appeared to have an eyelash in the sterile packaging.Hospital was not made aware, as it did not impact the case.The female patient was not affected and was last known to be in stable condition following the event.The device will be returned for evaluation.
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