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Model Number 7209485 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/05/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a meniscus repair surgery, the meniscus mender ii disposable set was found to be damaged before use, a photo shows both loop's heads unsoldered/detached from the shaft.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10 h3, h6 one disposable meniscus mender ii set used for treatment, was returned for evaluation.Visual assessment confirmed the complaint.The loop meniscal were broken from the bottom.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.Use of the distal end (head) to remove snare loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.Proper method of retrieval is to push and pop the head of the component from the back of the cradle.E1 additional correct information: (b)(6) and address (b)(6).
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Search Alerts/Recalls
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