The implant(s) was not returned and instead the investigation will be done based on the supplied image the image(s) was reviewed and the complaint condition could not be confirmed since there was no allegation against the device and no malfunction, damage, or defects on the x-ray.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: manufacturing location: (b)(4), manufacturing date: 14-mar-2013, part number: 04.034.349, 9mm ti cann tibial nail - ex w/prox bend 345mm, lot number: 7311949 (non-sterile).Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to irritation or pain while exercising¿ does not indicate breakage of the nail.Therefore, review of the raw material would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.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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