Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the flexible reamers were used to widen the isthmus of a canal during a revision of a cemented hip stem.The cement had been removed prior to the surgeon attempting to widen the narrow isthmus for the long revision stem.The guide rod was used to ream the canal, but when the flexible shaft was removed, the reamer head was not on it.The surgeon attempted to retrieve the reamer head, but decided to leave it in situ.The procedure was completed successfully.This report is for one (1) 10.0mm medullary reamer head.This is report 1 of 3 for (b)(4).
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