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 product: tls compression device; catalog#: 00-2490-101-22; lot#: unknown.Cmf torque limiting handle; catalog#: 00-2490-101-24; lot#: unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).The following reports are associated with this event: 0009613350-2022-00063.
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Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Review of event description: it was reported that the initial surgery was performed with a cmf nail system on (b)(6), 2021.Two weeks post surgery, the surgeon confirmed through x-rays that the lag screw was sliding to the outer side.The surgeon is keeping an eye on the patient condition and no revision surgery has been planned so far.It is additionally mentioned that the lag screw has not been inserted with the full telescoping length and that the tls compression device as well as the torque limiting handle were used.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Review of complaint history identified additional similar complaints for the reported item and additional complaints for the reported part and lot combination related to the event for the lag screw and no similar complaints for the nail.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 according to surgical technique.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.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 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 initial surgery was performed with a cmf nail system on (b)(6), 2021.Two weeks post surgery, the surgeon confirmed through x-rays that the lag screw was sliding to the outer side.The surgeon is keeping an eye on the patient condition and no revision surgery has been planned so far.It is additionally mentioned that the lag screw has not been inserted with the full telescoping length and that the tls compression device as well as the torque limiting handle were used.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.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.According to the current available information, there are no confirmed product nonconformity, design or manufacturing issues related to the event.A possible contributing factor for the migration could be a malreduction or a really unstable fracture, as confirmed by an hcp review.However, by considering these factors and the corresponding use of the system, good results can be expected even in this demanding situations.It is also mentioned that a minor backout of the tls is not a clinical issue.Based on the available information it is not possible to determine the root cause for this issue.However, a further and more comprehensive investigation is undergoing and captured in (b)(4).Zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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