A true evaluation could not be completed as there was very limited information provided by the end user.The product is not available for return, the lot number is unknown, and there are no pictures available.However, the complaint was originally reported to j&j (codman), which indicates that the device was purchased through codman or marked with the codman name.Symmetry surgical acquired the codman line in 2012.There has been a total of (b)(4) sold of this device since 2012 with 1 additional complaint recorded for similar occurrence.The root cause of the additional complaint was found to be wear and tear of the device with over 20 years of use.Based on the information provided above and the lack of information from the customer, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or corrective actions needed, a follow-up report will be submitted.The delay in the fda receiving this complaint was due to a change in esignature certificates.
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