This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical product: z nail cmf 10mmx17.5cm 125r; catalog# 47249818010; lot#3052799; z nail cmf 5.0x70 ant sup scr; catalog# 47-2501-070-50; lot# 3069176; z nail cmf nail cap 0mm; catalog# 47-2500-002-00 lot# 3056987; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog# 47-2484-025-50; lot# 64568583; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog# 47-2484-025-50; lot# 64930569; therapy date: (b)(6) 2021.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
|
This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: the name of the surgeon.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).
|
This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that an operation was performed with cm fortis nail system on (b)(6), 2021.After the initial operation, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.Therefore, revision surgery was conducted on (b)(6) 2021 and all implants were explanted.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: four undated ap x-rays of the right hip were received in a pdf.Assuming that the order of the x-rays is chronologically it can be seen that there is a migration of the telescopic lag screw.Further it is noted by hcps that fracture reduction and tls placement was not ideal.The femoral head has been rotating due to poor restoration.Therefore, the outcome (surgical intervention) of this event is less likely related to an implant issue but potentially due to the unstable fracture reduction and/or placement of the tls in the initial surgery.Images: several images were received of the device.However since the device was received as well the images were not further investigated.Product evaluation: visual examination: all revised components were received for investigation.The tls show wear marks on the outer as well as on the inner sleeve on one side.The wear marks consist of small abrasions.In another area long coarse scratches can be observed on the outer sleeve.The thread of the tls also shows some polishing.The nail show wear marks most likely by the drill on the inside of the bore hole for the tls in the proximal lateral area.Additionally, the distal edge of the medial side of the bore hole shows wear marks in form of small lines.Further, the nail was disassembled to investigation the set screw.The two holding tips of the set screw shows small areas of wear.Other than that some screw marks can be observed on the distal screw holes.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.Ncr(s): for ref.47-2499-090-10 / lot 3054638: 1 part was scrapped due to a bore hole axis position beeing outside the tolerances.11 parts were scrapped due to the diameter of the bore hole being outside the tolerances.1 part was scrapped due to the outer diameter being out of specification.28 parts were scrapped due to scratches on the surface.For ref.47-2498-180-10 / lot 3052799: no ncr found.Surgical technique: the correct implantation and insertion (tls placement and set screw locking) is described in the surgical technique.Please also note the following section regarding set screw locking: after the tls is placed, the pre-assembled set screw in the nail must be tightened with the torque limiting handle offered with the system, to prevent the tls sleeve from moving post-operatively.An anterior support screw can be placed in addition to the tls to provide rotational stability and support the treatment of unstable intertrochanteric fractures with large posteromedial (lesser trochanter) and posterolateral (greater trochanter) fragments, preventing excessive lag screw sliding post-operation.Conclusion: it was reported that an operation was performed with cm fortis nail system on (b)(6) 2021.After the initial operation, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.Therefore, revision surgery was conducted on (b)(6) 2021 and all implants were explanted.Based on the received x-rays a migration of the telescopic lag screw can be confirmed.Further it is noted by hcps that fracture reduction and tls placement was not ideal.The femoral head has been rotating due to poor restoration.Therefore, the outcome (surgical intervention) of this event is less likely related to an implant issue but potentially due to the unstable fracture reduction and/or placement of the tls in the initial surgery.All revised products were returned and the visual evaluation.All revised components were received for investigation.The tls and the nail show wear marks and scratches consistent with the migration.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).It is noted that the fracture reduction and tls placement was not ideal and that the femoral head has been rotating due to poor restoration.Therefore, it can only be assumed that the reported event is potentially related due to the unstable fracture reduction and/or placement of the tls in the initial surgery.However, based on similar complaints due to tls migration a more comprehensive investigation is undergoing to determine the necessity of potential corrective and/or preventive actions.According to the current available information, there are no confirmed product nonconformity related to the issue.There are also no known design or manufacturing related issue to the znn cm fortis nails and lag screws at this time.A possible contributing factor for the migration could be a malreduction or a really unstable fracture.By considering these factors and the corresponding use of the system, good results can be expected even in this demanding situations.This is also confirmed by an hcp review.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
|