The received sample was found in opened original packaging including cover foil.One blade is broken off but included in gauze.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The received instrument was investigated.It was obvious that the scissor blade was broken.The cross section of the fracture was investigated more detailed.The fracture surface did not show signs of corrosion.Further signs indicating the cause of the fracture were not found during the investigation.A 100% functional test is performed during production, which ensures that the instrument fulfills the specification before it will be delivered.Therefore, it can only be assumed that issue was caused afterwards during handling, but this cannot be verified.No root cause identified as no signs were found indicating the cause of the fracture.A manufacturing or design related root cause for the damage of the complained device has not been identified.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).
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