Model Number 22-4035 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2023 |
Event Type
malfunction
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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 a rotator cuff repair, when the firstpass suture passer was used, its mandible fractured, which prevented the proper passage of the stitch.The procedure was completed using a back-up device.It is unknown if there was a delay.No further complications were reported.The patient status is stable.
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Event Description
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It was reported that during a rotator cuff repair, when the firstpass suture passer was used, its mandible fractured, which prevented the proper passage of the stitch.All parts were removed, they came out complete upon device's removal.The procedure was completed without delay using a back-up device.No further complications were reported.The patient status is stable.
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Manufacturer Narrative
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H2: additional information on b5 and h6 (health effect - impact code).
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Manufacturer Narrative
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H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.An analysis of the customer provided image found the mandible of the first pass suture passer fractured.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.¿se pega el roi¿.
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Search Alerts/Recalls
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