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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARCUS TWIST PEEK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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PARCUS TWIST PEEK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number 11349
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.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.
 
Event Description
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 is 13 of 13 complaints reported from the same clinic.
 
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Brand Name
TWIST PEEK SUTURE ANCHOR
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
PARCUS
6423 parkland drive
sarasota FL 34243
Manufacturer Contact
le van
6423 parkland drive
sarasota, FL 34243
MDR Report Key14829924
MDR Text Key295060302
Report Number3007319107-2022-00013
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number11349
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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