Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Additional device product code is hrx.(b)(4).Device is an instrument and is not implanted/explanted.The subject device expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Date of manufacture is unknown.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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It was reported that during a graft harvesting procedure on (b)(6) 2016 with the reamer-irrigator-aspirator (ria) system three devices broke, a drive shaft for ria, a 12.5mm reamer head, and a 13.5mm reamer head.Fragments were generated but were easily removed.The procedure was completed with back up devices.There was a ten (10) minute surgical delay due to the reported event.The patient is reportedly stable.The procedure was successfully completed.Concomitant device reported: locking clip for ria, sterile (part # 352.260s, lot # unknown, qty(b)(4)).This report is 3 of 3 for (b)(4).
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The initial complaint was reviewed and found not reportable.It was confirmed that device 13.5mm reamer head-sterile for reamer/irrigator/aspirator (part # 352.253s) was inadvertently reported.There is no allegation against this device.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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