MAUDE Adverse Event Report: PARCUS MEDICAL LLC BIOCOMPOSITE SUTURE ANCHORS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 11126

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by parcus or its employees that the report constitutes an admission that the device, parcus, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 it was reported to parcus that during a rotator cuff shoulder procedure on a patient of unknown age and demographics, the anchor broke when inserting.There was no defect with the device or packaging observed prior to use of the anchor.There was no negative patient impact reported.There was no delay in the procedure reported.Additional information was solicited.

Manufacturer Narrative

This complaint is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: the reported event is not confirmed.Additional information was not provided upon request.The current status of the patient is unknown.A review of the batch record was performed.There were no nonconformances related to the reported event in the manufacturing record.The lot was manufactured and released to applicable procedures and specifications.A three year retrospective review of all nonconformances was performed.There was no nonconformance for this part number.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

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by parcus or its employees that the report constitutes an admission that the device, parcus, or its employees caused or contributed to a potential patient event documented on this report.On 02april2024 it was reported to parcus that during a rotator cuff shoulder procedure on a patient of unknown age and demographics, the anchor broke when inserting.There was no defect with the device or packaging observed prior to use of the anchor.There was no negative patient impact reported.There was no delay in the procedure reported.Additional information was solicited.

• Brand Name: BIOCOMPOSITE SUTURE ANCHORS
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): PARCUS MEDICAL LLC; 6423 parkland drive; sarasota FL 34243
• Manufacturer Contact: kerith kelly ; 6423 parkland drive; sarasota, FL 34243
• MDR Report Key: 19153702
• MDR Text Key: 341239327
• Report Number: 3007319107-2024-00007
• Device Sequence Number: 1
• Product Code: MAI
• 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: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11126
• Device Lot Number: 16182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1