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Catalog Number 03.037.010 |
Device Problem
Failure to Align (2522)
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Patient Problem
Sedation (2368)
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Event Date 03/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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This device was used for treatment, not diagnosis.Additional narrative: (b)(4).Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.There were no nonconformances generated during production that would contribute to the 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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Event Description
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It was reported that during a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2016, a misalignment occurred.The patient presented with a proximal third shaft fracture as a result of a motorcycle accident.The patient was said to have hard bone and the canal was narrow.The surgeon selected a tfna due to the features.The fracture was reduced with a serrated reduction clamp, the bone was reamed as appropriate and the surgeon advanced the nail into the bone.While advancing, the guide wire position was superior in the femoral head and neck and the surgeon wanted it inferior.The surgeon pulled the guide wire back, and advanced the nail distally.The nail seemed to be ¿maxed out¿ as the flare on insertion handle hit the top of the greater trocar and would not allow the nail to advance any further.The nail did advance slightly.The surgeon inserted the first guide wire for the helical blade and under imaging realized the wire was bent and removed it.A second identical guide wire was inserted and it appeared that the wire was taking the original path before they made the adjustments with the nail.The lateral cortex drill bit was used to drill for the helical blade and collided with the nail; nail fragments remained embedded in the patient.The surgeon tried to advance the drill bit and it would not advance any further due to hard bone and/or fighting the guide wire per to radiographic images.The surgeon attempted to insert the helical blade and it would not advance all the way; therefore, the surgeon removed the helical blade.The sizes of all devices being used were verified and everything matched appropriately; it was suspected there was a misalignment.The surgeon attempted to insert another wire and at the same time the canulet, the internal sleeve for the wire fell on the floor.The surgeon requested a trochanteric fixation nail (tfn) instead and the entire tfna construct was removed completely; some fragments remained in the femoral neck from the drill bit striking the nail.A tfn was inserted and the case was completed successfully.There was no additional harm to patient nor was any additional medical intervention to remove the fragments reported.There was a surgical delay of 90 minutes due to the malfunctions, trouble-shooting intra-operatively, attempts to reinsert instrumentation and having to abandon initial work to use a different system.Post-operatively after sterile processing, the equipment was inspected and it was noticed that the drill bit and helical blade assembly (helical blade and inserter) would not advance through the threaded sleeve.The tfna construct was reassembled and it was confirmed that there was a misalignment.This is report 7 of 8 for (b)(4).
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Manufacturer Narrative
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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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Event Description
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During evaluation of the complaint by the manufacturer additional information was received.The nail had a tight fit within the bone, making it difficult to adjust its position after insertion.After the guide wire for the head element did not follow the desired trajectory, the surgeon tried to rotate the nail using the insertion handle while keeping the guide sleeve lowered down to the bone.The opposing forces from the bone pressing on the edge of the guide sleeve and the aiming arm rotating with the nail caused the guide sleeve to bend near the taper.The bent guide sleeve was now misaligned with respect to the nail, causing the lateral drill bit to collide with the nail.The bent sleeve also prevented the helical blade inserter from passing through, which made it impossible to fully insert the helical blade.
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Search Alerts/Recalls
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