Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records was conducted.The report indicates that themanufacturing location: dhr review part number: 314.742 synthes lot number: 7081941 release to warehouse date: 22-jul-2013 supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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A product investigation was completed: the complaint condition was able to be confirmed at customer quality as the reamer head was returned broken at the base of the four (4) fingers.The broken portions were not received.Replication of the complaint is not applicable as the device was returned broken.One drive shaft and one ria tube assembly were received stuck together.The items were sent through decontamination, but were unable to be completely cleaned as they could not be disassembled.The tube assembly still contains a small amount of blood.The tip of the drive shaft (within the tube) shows some evidence of damage, which may have come from the broken reamer head.This may explain why the items cannot be separated.The end of the drive shaft does not show any signs of damage outside of normal wear and tear.The ria tube assembly has some unknown debris on the inside of it.The exterior does not show any signs of damage outside of normal wear and tear.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.Per the technique guide a cannulated drive unit that delivers only 3.5-4.5nm of torque and 700-900rpm is to be used.The technique guide also cautions that no reduction drive units or drills with a torque greater than 6nm should be used.During use, the drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.Product drawings for the reamer head, drive shaft, and tube assembly were reviewed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The complaint condition is the result of an overload of forces to the distal end of the drive shaft resulting in stresses beyond the failure limit.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the 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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