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Catalog Number 7205305 |
Device Problem
Corroded (1131)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/06/2019 |
Event Type
malfunction
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Event Description
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It was reported that during an acl reconstruction surgery, the planer has rust spots and cannot be used.Additional information was received and was confirmed that the device was used in the patient.No patient injury or significant delay were reported.Back up device was available.
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Manufacturer Narrative
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One 7205305 3.5mm full radius disposable blade used for treatment, was returned for evaluation.The complaint stated: ¿the planer has rust spots and cannot be used.Additional information was received and was confirmed that the device was used in the patient.No patient injury or significant delay were reported.Back up device was available.¿ the device is in good condition.Silicone is used in during manufacturing along with a silver plating process.The silver plate surface may become discolored.Visual inspection indicated evidence of silicone and silver tarnish discoloration.To produce a device with less friction, silicone is used for additional lubrication between inner and outer blades.This may encourage subsequent tarnish of the silver.It has been determined that the excess silicone located at the bottom of the blade tip, or the appearance of discoloration will not impact the patient or end user.¿surillium is the proprietary, silver coating that helps prevent shedding.It improves lubricity and allows for reduced frictional contact between the stainless steel inner and outer blades.It also discolors when exposed to certain elements.The red substance that's occasionally found on our blades and peaks curiosity of our customers is actually a silicone lubricant from the manufacturing process.Testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.¿ the silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.This observation is monitored through surveillance.Complaint history lot review found no other complaint for this lot.Product met specifications upon release to distribution.
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Search Alerts/Recalls
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