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Model Number 72290128 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that during use in a right knee medical meniscus root repair, using the "firstpass mini straight", when the needle deployed the minitape through the root of the meniscus, the suture catch mechanism completely detached from the upper jaw and was floating around loose in the joint.The loose suture catch was retrieved with an accessory portal from the back of the knee joint.A delay of 10 minutes was reported and the procedure was finished with a smith and nephew back up device.No other complications were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows a detached suture capture.No manufacturing abnormalities.A functional evaluation revealed the needle will deploy when trigger is initiated, the suture capture is detached and missing.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A review of the customer provided image shows a detached suture capture.A clinical review states one undated photo of the device was provided for review and confirms the reported.It was communicated via e-mail that the detached suture catch mechanism was retrieved from the patient.The procedure was completed using a back-up device.It was also noted that the patient is doing well.Based on the limited information provided the root cause of the breakage could not be concluded and we are currently unable to rule out a procedural variance as a contributing factor.No further clinical/medical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that during use in a right knee medical meniscus root repair, using the "firstpass mini straight", when the needle deployed the minitape through the root of the meniscus, the suture catch mechanism completely detached from the upper jaw and was floating around loose in the joint.The loose suture catch was retrieved with an accessory portal from the back of the knee joint.A delay of 10 minutes was reported and the procedure was finished with a smith and nephew back up device.No other complications were reported.Patient is well.
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Search Alerts/Recalls
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