The devices were discovered broken on (b)(6) 2017; it is unknown when they broke.Device is an instrument and is not implanted/explanted.Contact phone number: (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: may 20, 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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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Product development investigation was completed.The report indicates that the: article 356.220 lot f-11020; the visual inspection of the returned drill bit has shown scratches on the coupling.The cutting part of the drill bit is very short and approximately 30mm of the cutting edges are missing.Further investigation has shown that this instrument was manufactured in may 2010.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.As the cutting tip and edges are still available but approximately 30mm are missing we can assume that the part was re-sharpened several times.Device 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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