CONMED LARGO INFINITY AIM MENISCAL REPAIR DEVICE, 15 DEG. REVERSE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number KMR2R |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Additional fda product code: the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation this issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the, kmr2r, infinity aim meniscal repair device, 15 deg.Reverse was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction with meniscal repair & posterolateral repair when it was reported ¿2nd cleat broke during tensioning.¿ further assessment questioning found that ¿peak cleats were not retrieved from surgical site, behind capsule.¿ the procedure was completed with the use of double ended sutures and a one-hour delay was reported during the procedure.There was no report of medical intervention or extended hospitalization required for the patient.The current status of the patient is ¿recovering¿.This report is being raised on the basis of injury due to patient retaining fragmentation of the device.
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Manufacturer Narrative
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Additional fda product code: gat manufacturer narrative: the reported event of the cleat breaking is unconfirmed.Customer complaint cleat broke during tensioning was not confirmed.Examination of the returned used, item kmr2r could not confirm the reported problem.Removed both handles for one of the devices and could not find any discrepancies with assembled components.Both implants and the suture have been deployed for one of the returns.Sleeve adjuster and the wheel performed as intended during the test.No fault found with returned device.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame 1,637 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.008.Per the instructions for use, the user is advised the following: bending of the device may prevent proper insertion and/ or damage the implants and/ or suture/ compromise needle structural integrity.The device should not be used as a lever.Improper insertion technique nay cause breakage of the device, implants and / or suture or premature failure.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the, kmr2r, infinity aim meniscal repair device, 15 deg.Reverse was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction with meniscal repair & posterolateral repair when it was reported ¿2nd cleat broke during tensioning.¿ further assessment questioning found that ¿peak cleats were not retrieved from surgical site, behind capsule.¿ the procedure was completed with the use of double ended sutures and a one-hour delay was reported during the procedure.There was no report of medical intervention or extended hospitalization required for the patient.The current status of the patient is ¿recovering¿.This report is being raised on the basis of injury due to patient retaining fragmentation of the device.
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