Additional narrative: udi: (b)(4).Investigation summary:the device was received and evaluated.When performing the visual inspection, the first device had the sleeve damage.The implants were not returned.The trigger was tested several times, it performed as intended, the pusher rod has no structural anomalies.A manufacturing record evaluation was performed for the finished device 8l67573 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the sleeve condition, this complaint can be confirmed.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; the damage in the sleeve can be attributed when is over penetrating the needle causing the silicon tube to move and damage, or not inserting the needle to the proper depth for deployment.Based on the ifu, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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