ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 11.5MM X 32CM 125 L; ZIMMER NATURAL NAIL SYSTEM FORTIS NAIL, LONG LEFT
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Model Number N/A |
Device Problems
Patient Device Interaction Problem (4001); Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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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 medical product: z nail cmf 10.5 x 105 lag scr; item#47249910510; lot#3065731; z nail cmf nail cap 0mm; item# : 47250000200; lot# : 3056988.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; item# : 47248403550; lot# : 64923937.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; item# : 47248404250; lot# : 64661205.Z nail cmf 5.0x85 ant sup scr; item# : 47250108550; lot# : 3050807.Therapy date: unknown.The manufacturer received x-rays and other source documents for review.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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Event Description
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The patient received an implant on left side and 4 weeks post the implantation surgery, radiological findings revealed that the lag screw migrated towards the outer side.The patient is being monitored and no revision has been planned so far.
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Manufacturer Narrative
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Additional information which was received on sep 03, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: e1, h2.Corrections: b4, g3, g6, h10.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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Event Description
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The patient received an implant on left side and 4 weeks post the implantation surgery, radiological findings revealed that the lag screw migrated towards the outer side.The patient is being monitored and no revision has been planned so far.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient received an implant on jul 21, 2021 and 4 weeks post the implantation surgery, radiological findings revealed that the lag screw migrated towards the outer side.The patient is being monitored and no revision has been planned so far.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.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.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: 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.Conclusion: it was reported that the patient received an implant on jul 21, 2021 and 4 weeks post the implantation surgery, radiological findings revealed that the lag screw migrated towards the outer side.The patient is being monitored and no revision has been planned so far.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 an 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).
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Event Description
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No change to previously reported event.
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Search Alerts/Recalls
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