Analysis of historical records.Orthofix (b)(4) checked the internal records related to the controls made on the device code 1355001, lot 273357 before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.All of them have already been released to the market.Technical evaluation: the returned drill bits, received on july 11th, 2018 were examined by orthofix (b)(4) quality engineering department.The devices were subjected to visual, dimensional and functional check as per orthofix (b)(4) specification.The visual and dimensional check did not evidence any anomalies.The functional check was performed on the returned devices compared to drill bits taken from the stock.It was confirmed that the returned drill bits, manufactured by a new supplier, have a slightly lower cutting performance than the drill bits produced by the previous supplier.Medical evaluation: the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluations performed.This report states the following: the supplied drill bit was unable to drill a hole in the forearm bones of this patient.A second drill bit from another kit had the same problem.A smith & nephew drill bit was used instead and performed normally (i.E.Drilled the required hole).It was noted that the orthofix 2.7 mm drill bits were both hot when removed.The distributor has noted that the drill bits were able to drill though a sawbone, but not real bone.The report is quite correct in stating that there is a risk of heat necrosis in this case.We do not know how far the drill bits penetrated the bone, but we do know that the drill bits became significantly heated.If the temperature of the bone is raised above 47 degrees c, cell necrosis is likely.This could produce a ring of dead bone around an inserted bone screw, and this might lead to bone screw and therefore fixator loosening.The bone might look quite normal, but the cells within it may have been killed by the heat produced by drilling.Final comments: the results of the technical evaluation confirmed that the returned drill bits, manufactured by a new supplier, have a slightly lower cutting performance than the drill bits produced by the previous supplier.However, this difference does not compromise the possibility to complete the drilling step.Orthofix (b)(4) continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2018-00058.
|
The information provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon's name: dr.(b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: upper extremity.Distal radius fractures; surgery description: fracture treatment; patient information: unknown; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem.Event description: the surgeon could not drill the bone with a drill in the radiolucent wrist fixator pack.He opened another pack and drilled, but again experienced the same event.Finally he used the s&n drill because the two drills could not drilling the bone and the drill was very hot.There was a possibility that the patient became heat necrosis.The drilling force of the drill bit was bad compared to usual.In our investigation the drill could drill the sawbone.The complaint report form also indicates: the device failure had adverse effects on patient (risk of heat necrosis) the initial surgery was not completed with the device: it was used a replacement device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure: an additional surgery was not required; a medical intervention (outpatient clinic) was not required; copies of the operative reports are not available; copies of the x-ray images are not available ; patient current health condition: unknown.Further information received on june 29, 2018.There were adverse effects on patient: it is just the possibility of heat necrosis current health condition of the patient: we have not heard from our customer that there are adverse effects on the patient.(b)(4).Please kindly refer also to mfr report number 9680825-2018-00058.
|