Catalog Number 79-43910 |
Device Problems
Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device was discarded at the facility; however, pictures were supplied to the manufacturer.
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Event Description
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It was reported that prior to surgery, the surgeon proceeded to open the hydroset packaging and noticed that there was a hair in half of the sterile portion and half outside the sterile packaging.The company representative was not available for the case.
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Manufacturer Narrative
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A confirmation of the reported event was not applicable because neither the complained device nor a photo evidence was provided for investigation.The investigation conducted is based on the reviews of the batch manufacturing records (bmr).The device is manufactured by (b)(4).So the complaint information was forwarded to the manufacturing facility.The reviews of the bmr were completed and no discrepancies were recorded.It has been confirmed that the product and its components (liquid and powder components) were manufactured per validated conditions.Further possible root causes for the potentially identified hazard (particle/debris) are according to the risk management file: excessive forces (e.G.Moving, positioning, holding).Wrongly assembled instruments/ implants.Occurring during shipping/ transportation.Based on the evaluation no indications for any design, material or manufacturing related problems were found in this investigation.Device was not returned.
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Event Description
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It was reported that prior to surgery, the surgeon proceeded to open the hydroset packaging and noticed that there was a hair in half of the sterile portion and half outside the sterile packaging.The company representative was not available for the case.
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Search Alerts/Recalls
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