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Patient information is not available for reporting.This report is for an unknown guide wire.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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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Device report from synthes on an event in (b)(6) as follows: it was reported that the nurse called the sales rep on (b)(6) 2017 and told him that they have problems during the surgery.They were about to remove a proximal femoral antirotation blade (pfna) and had accidently used a wrong guide wire and when the used the extraction screw, the tip broke into the pfna blade.The blade could not be removed, and they tried to get it out.The sales rep suggested to organize an instrument set for pfna blade removal but the nurse said that this would take too long time.The nurse would talk to the surgeon, and would return if they needed the instrument set for pfna blade removal.The sales rep did not heard from them.The surgery was prolonged to an unknown time.No information available about patient condition and outcome.It was reported that the patient had post-operative pain and thought this was because of the implanted proximal femoral antirotation (pfna) implants ((b)(4)).They could not remove the implant, and have closed the site, and will now plan and order instrument for removal of damaged pfna blade.The blade is still in the patient.The broken off piece of the extraction screw is stuck in the implanted blade.The surgery was not successfully completed.The hook sticking to the blade happened when the blade removal tool was used to get the blade out (see attached update).This event is reported under linked complaint (b)(4).Concomitant device reported: pfna ø10 long le 130° l340 tan (part # 472.325s, lot # 9722611, quantity 1).This report is for an unknown guide wire.This is report 3 of 3 for complaint (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Event : updated information.Unk - guide/compression/k-wire.Investigation summary: the visual inspection of the returned parts has shown strongly damages on the surface of the blade.The instruments shows strongly damages possibly while trying to remove the implant with a pliers f/removal of pfna-blades.Additionally, it is also visible that the extraction hock is bent and stuck inside the blade together with a unknown guide wire.There is also the tip section of the reported extraction screw 03.010.411 visible which also stuck inside the blade.As all the parts are stuck tight together we are not able to detach the parts from each other.The nail which was also returned for evaluation is intact and shows just some damages around the oval hole.Additionally there are scratches on the surface visible.The investigation of the extraction screw 03.010.411 was already performed in etq under complaint (b)(4) here the investigation result.As received condition of device: the instrument was not delivered in the original packaging.Laser marking was readable.The piece generated from the breakage was not delivered for investigation; is missing.The piece with the thread m7x1 lh and hexagon on it, is (as indicated in the complaint description) still in the implanted blade ¿the broken off piece of the extraction screw is stuck in the implanted blade.¿ the "investigation summary" is a conclusion from previous document(s).A dhr check was performed for the affected product 03.010.411 lot 7744954 work order and components.The dhrs were reviewed and no issue or deviation, neither ncs were found which could lead to the complaint condition.The component article was not checked because they are not relevant to the complaint condition.As relevant for the complaint condition; ¿the tip of the extract screw was broken, and is still in the implanted blade¿ the position, the inner diameter as well as the hardness were identified and measured.All features measured are according to the and have passed the specification through the gauges.As this instrument is broken, the hardness was also measured, specifically on the diameter as close as possible to the region broken; the results show that has passed its manufacturing specifications'.The hardness was also tested during manufacturing process through the inspection sheet as well as through a protocol from a supplier ¿härterei schmid ag¿.Besides, during the manufacturing process, the features m7x1 lh and hex 4.5 were inspected 100% and documented according to the inspection sheet and the whole lot size has passed its specifications; no deviations neither scrap was detected.The lots of the raw material of the component are not tracked by a lot number.Therefore, the check was performed based on fifo (first in/first out) by investigation of the raw material orders, which was closest to the start of the manufacturing order of the component.Thus, the raw material used fulfilled the specifications.This complaint is confirmed since the instrument is broken as claimed by the customer.However, according to the investigation results and from the manufacturing point of view this complaint is rated as not valid because the relevant dimensions were measured and have passed the specifications and no manufacturing issue could be found in the results neither in the manufacturing documentation reviewed (dhr, material certificate, etc.).As this complaint is not valid therefore the review of the specific prm and pra line is not applicable.This complaint is confirmed since the instrument is broken as claimed by the customer.However, according to the investigation results and from the manufacturing point of view this complaint is rated as not valid because the relevant dimensions were measured and have passed the specifications and no manufacturing issue could be found in the results neither in the manufacturing documentation reviewed (dhr, material certificate, etc.).As this complaint is not valid therefore the review of the specific prm and pra line is not applicable.The review of the production history of the pfna blade 04.027.033s revealed that this implant was manufactured in august 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.The review of the production history of the extraction hook 03.010.172 revealed that this instrument was manufactured in march 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.The review of the production history of the nail 472.325s revealed that this instrument was manufactured in december 2015 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.Unfortunately we are not able to determine the exact cause which has led to the reported problem.We can only assume that several mechanical overload situation during removal of the implant in conbination with the accidentely used wrong guide wire which was reported in the complaint description has led to the breakage of the extraction screw.We would like to mention to the surgical technique were it is states that in certain cases, especially in younger patients with good bone quality, the pfna/pfna-ii blade can not be removed with the standard surgical technique.In the case of implant removal, complications may arise for a variety of reasons and it is important that the surgeon should be prepared for this.In addition to extraction instruments such as screwdrivers, instruments to extract damaged and broken implants should also be readily available.The synthes pfna/pfna-ii blade extraction set is a special set containing instruments for the extraction of the pfna/pfna-ii blade in certain situations where the instruments of the standard set are not sufficient.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device 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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