(b)(4).Examination of the submitted neuflex mcp2 and mcp5 confirmed fracture and cracking due to fatigue cracks that initiated in the corners of the hinges.Due to excessive rubbing of the fracture surfaces, a cause of failure could not be determined for the neuflex mcp4.Examination of the implants¿ fracture surfaces by sem revealed no apparent material defects.Review of supplied x-rays did not provide any information to aid in the determination of the root cause of the implant fractures associated with this complaint.From a medical perspective, based on the very limited information available, it is not possible to determine if the complaint is product related.Review of the device history records and/or a lot specific complaint database search was not possible as the product lot codes required were not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.The ifu for the product (ifu-0902-00-710) identifies failure of the implant due to fatigue, wear or overloading as an adverse effect and complication.Additionally the warnings and precautions section includes the following information: ¿if excessive loading of the affected finger joint cannot be prevented, a finger joint implant should not be used.¿ depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.25 august 2015 - reopened complaint to update, add product lot codes.A complaint database search finds no additional reports against the provided product and lot combination.The investigation could not verify or identify any product contribution to the reported event with the newly information provided.Based on the inability to identify root cause or evidence of product error as a contributing factor, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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