Additional narrative: udi: (b)(4).The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.Investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot: no lot numbers were supplied which precludes conducting a dhr review or a lot-specific search in the complaints handling system.
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It was reported by the affiliate in (b)(6) that during a shoulder repair procedure on an unknown date, it was observed that the retention plate on the exprsew iii ac+ rtn plate device was not removed after the end of the surgery.According to the report, a second plate was put on top for a new surgery as the plate fell inside the patient.It was reported that although fragments were generated and were not removed, the procedure was completed successfully.It was reported that an x-ray was performed after the surgery on the patient.It was reported that the patient was scheduled to have a second surgery to remove the plate.The status of the patient post-surgery was unknown.No additional information was provided.
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