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Catalog Number 11349 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new and relevant information and or the completion of the investigation by the manufacturing plant.
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Event Description
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On (b)(6) 2022, it was reported to anika that a physician performed a procedure on a patient of unknown age and demographics with the parcus screw in suture anchor system on an unspecified date.After the initial procedure the patient was advised to follow the willits accelerated achilles rehab protocol.On an unspecified date, the patient reportedly experienced swelling and pain.A revision procedure was performed on an unspecified date to remove the excessive scar tissue near the 2mm suture on the patient's achilles tendon.The surgeon reported that was no issue with the anchor and no issue with the bone or boring.The excessive scar tissue was removed which resolved the issue with the patient's pain and swelling.The surgeon reported that the patient was not immunocompromised, there was no infection, no fluid was present, and no biologics were used during the initial procedure.There were no concomitant devices used with the screw in suture anchor system.There was no report of any issues with the appearance of the device and components and packaging.The product is stored in a sterile unit in the hallway at the clinic.The lot number of the device was not reported by the surgeon or distributor of the device.
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Event Description
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On (b)(6) 2022, it was reported to anika that a physician performed a procedure on a patient of unknown age and demographics with the parcus screw in suture anchor system on an unspecified date.After the initial procedure the patient was advised to follow the willits accelerated achille rehab protocol.On an unspecified date, the patient reportedly experienced swelling and pain.A revision procedure was performed on an unspecified date to remove the excessive scar tissue near the 2mm suture on the patient's achilles tendon.The surgeon reported that was no issue with the anchor and no issue with the bone or boring.The excessive scar tissue was removed which resolved the issue with the patient's pain and swelling.The surgeon reported that the patient was not immunocompromised, there was no infection, no fluid was present, and no biologics were used during the initial procedure.There were no concomitant devices used with the screw in suture anchor system.There was no report of any issues with the appearance of the device and components and packaging.The product is stored in a sterile unit in the hallway at the clinic.The lot number of the device was not reported by the surgeon or distributor of the device.This case is one of 13 reported by the same clinic.
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Manufacturer Narrative
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This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new and relevant information and or the completion of the investigation by the manufacturing plant.Supplemental information: correction: d1.This case is one of 13 cases reported by the same physician.Additional information was solicited and not provided.There was no device malfunction or issues of appearance reported at the time of use.The current status of the patient is unknown.The lot number was not provided upon request.Therefore, a review of the device batch record could not be performed.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.
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Search Alerts/Recalls
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