Udi: (b)(4).The lot number was unknown.Investigation summary: the complaint device is not being returned, it was retained by the customer, 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.
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It was reported by the customer in (b)(6) that during a revision procedure performed on (b)(6) 2021 to an initial procedure of biceps tendon repair performed on (b)(6) 2021, the surgeon observed that there was a rupture on the thread flushed with the anchor on the gii qa+ o/c cp-2 device; and hence, there was final abandonment of the anchor; and that it remained in place in the bone.Therefore, the surgeon put a new anchor next to the old one using the same hole in the cortical bone.It was reported that upon tightening the two threads, one broke again in the anchor.The current status of the patient post-surgery was unknown.No additional information was provided.
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