The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since data were provided, the opinion of a medical expert was sought and stated as following: "to be able to assess this case the availability of the mri-images (and/or a report) would prove very helpful, as well as a report of both surgeries (.) because "the conflicting information in the ae description is that the mri showed a subscapularis tendon rupture and a lesser tuberosity avulsion (that is both at the anterior side of the shoulder), and that the surgeon had to repair the superior cuff (that is the supraspinatus tendon and parts of the infraspinatus tendon)", and also because "(.) an early postoperative mri is not very reliable for the detection of smaller lesions, because of these unavoidable artifacts.Only larger lesions with tendon retraction can be diagnosed more reliably on an early postoperative mri".Moreover, "we cannot be sure of the reason [why the patient noticed pain after physical therapy before been re-operated].The exercises may play a role in the event".It "depends on the additional information on status of the rotator cuff during the re-operation".More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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