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This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Medical products: z nail cmf 10.5 x 105 lag scr; catalog#: 47-2499-105-10; lot#: 3054644; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog#: 47-2484-030-50; lot#: 6509827; z nail cmf nail cap 0mm; catalog#: 47-2500-002-00; lot#: 3056979; z nail cmf 5.0x85 ant sup scr; catalog#: 47-2501-085-50; lot#: 3050783.Therapy date: unknown.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).
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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.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on sep 03, 2021 the manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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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.1.Event description: it was reported that the patient was implanted with cmf nail system on (b)(6) 2021.One week post implantation, from x-ray it was observed that the lag screw was sliding to outer side from the implanted position.The surgeon keeps monitoring the patient condition.No revision surgery is planned.Harm: s2 - instability, minor hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.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: two x-ray pictures have been received.On the post-op pictures it can be seen that the lag screw was slightly sliding to outer side from the implanted position.This can be seen on the post-op picture 2 weeks.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: all involved devices are 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.Surgical technique sap: review surgical technique sap 3045-jp-en rev 0: 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 setscrew 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.5.Conclusion: it was reported that the patient was implanted with cmf nail system on (b)(6) 2021.One week post implantation, from x-ray it was observed that the lag screw was sliding to outer side from the implanted position.The surgeon keeps monitoring the patient condition.No revision surgery is planned.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the affected products have met the specifications valid at the time of production.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.Based on the available information it is not possible to determine the root cause for this issue.A further and 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 a healthcare provider (hcp) review.It is also mentioned that a minor backout of the tls is not a clinical issue.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).The following reports are associated with this event: 0009613350-2021-00469-2.
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