Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Contact phone number: (b)(6).Manufacturing location: (b)(4).Manufacturing date: july 07, 2010.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: a visual inspection under 5x magnification, functional test, drawing review, and dimensional analysis were performed as part of this investigation.A definitive root cause cannot be identified with the limited complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.The drill bit was returned with a portion of the cutting flutes broken off and untwisted, likely from interference and/or excessive torsional load.The broken pieces were not returned with the complaint.Relevant dimensions could not be measured due to post manufacturing damage however it is unlikely that the design contributed to the complaint condition.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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