Integra has completed their internal investigation on (b)(6) 2017.As the lot number was not reported and the part not returned, a review of the lot record could not be conclusive.A review of the complaint records for the same product for the alleged hazardous situation/failure mode (insert inserter breaking) showed nine complaints for this instrument having been received during the lifetime of the product.As the staple was not returned, a likely root cause could not be determined.If the part is returned at a later date, this complaint will be reopened and updated.
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