Reporter is jnj representative.Investigation summary: 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 history lot; part number: 310.350; lot number: 2299948; manufacturing site: (b)(4); release to warehouse date: oct.26, 2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 (b)(6) reports an event as follows: it was reported on an unknown date the drill bit not functioning (cutting) properly.It was unknown when the occurrence happened, and how it happened.There is no procedure performed, and no patient was involved.This complaint involves one (1) devices.This report is for (1) drill bit ø3.5 l110/85 2flute.This is report 1 of 1 for (b)(4).
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