Patient initiated complaint received.Received a voicemail from patient informing about the broken implants of her left hand.She said, on her left hand, the middle finger is broken.This was implanted on (b)(6) 2015.Unable to provide the part and lot number of the products implanted.Currently the patient is wearing splints, she already have 3 splints and waiting for the last one.Patient said, she already spent (b)(6) of the splints alone.Her surgeon wasn't sure on what to do about her case.Apologized and empathized to patient.Explained to her about the authorization letter, this will be sent through mail.There is no revision reported at this time.Doi: (b)(6) 2015 : dor: not revised (left hand).Patient is bilateral, please see (b)(4) (right hand).
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Product complaint # = > pc-(b)(4) investigation summary = > no device associated with this report was received for examination.The investigation could not draw any conclusions regarding the reported event.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.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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