MAUDE Adverse Event Report: PARCUS TWIST PEEK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 11349

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Scar Tissue (2060); Skin Discoloration (2074); 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 information and or upon completion of the investigation by the manufacturing plant.

Event Description

On (b)(6) 2022, it was reported that a patient of unknown age and demographics experienced an increase in scarring after an unspecified procedure.The patient required a revision procedure on an unspecified date to remove the excess scar tissue on the tendon that was in contact with the 2mm suture tape.Discoloration at the incision site was also reported.No medical history provided.No concomitant products reported.Date of the implant is unknown.Additional information was solicited.

Event Description

On (b)(6) 2022, it was reported that a patient of unknown age and demographics experienced an increase in scarring after an unspecified procedure.The patient required a revision procedure on an unspecified date to remove the excess scar tissue on the tendon that was in contact with the 2mm suture tape.Discoloration at the incision site was also reported.No medical history provided.No concomitant products reported.Date of the implant is unknown.Additional information was solicited.This is one of 13 complaints reported by the same clinic.

Manufacturer Narrative

This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new information and or upon completion of the investigation by the manufacturing plant.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.A batch record review was performed on this lot.There was no non conformances recorded in the manufacturing records.The lot was released for commercial use on 26aug2020.The expiration date is 29jul2025.Additionally, the supplier confirmed that there were no changes in the design or process of for manufacturing.There were no prior reports of complaints from other clinics.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.

• 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: keith kelly ; 6423 parkland drive; sarasota, FL 34243
• MDR Report Key: 14518893
• MDR Text Key: 292993938
• Report Number: 3007319107-2022-00005
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11349
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention