Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: udi: the serial number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete.Udi: serial number unknown; (b)(4) unknown(21)unknown.
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It was reported from (b)(6) that during a hip surgery, it was discovered that while broaching the stem with the impactor device, the surgeons performed a repositioning and realized that there was a three millimeter (3mm) of too much leg length, and so they decided to put the broach a little deeper into the patients femur.The reporter indicated that the surgeons accomplished the task by using the impactor without applying force.It was further reported that in one moment, the device cracked the femur.According to the reporter, there was a long crack approximately ten centimeters (10cm) long, as a result, a 2x cerclage and a cemented stem was put in.It was reported that the plan was to operate both sides of the leg; however, due to the long delay in surgery and the risk of the patient to later apply too much force on the other leg, it was decided to complete only one side.It was reported that there were no fragments generated and the surgery was completed successfully.There was forty-five-minute delay to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were reports of injuries, medical intervention and/or prolonged hospitalization.It was reported that the incision had to be extended, post-operation treatment had to be adapted, the crack in the leg had to be cemented, and the second side of the leg was not operated on and had to be postponed to a later time.It was further reported that the bone quality was not as good as expected from the x-rays.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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