It was reported that a surgeon was using the supra-patellar tibial nail during a case and he was having problems with the protection sleeve.Surgeon was using a competitor reaming system which kept catching on the synthes protection sleeve which would then pull out from the incision.Also, the rubber protection sleeve loosened from the protection sleeve handle.Four parts where involved in the reported event, however was not certain which one(s) contributed to this issue.There was a 14 to 30 minute surgical delay due to the reported event.The procedure was successfully completed.This report is 3 of 4 for (b)(4).
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Device was used for treatment, not diagnosis.Additional narrative: (b)(6).Patient weight was not provided by reporter.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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