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

Catalog Number 11126T

Device Problem Break (1069)

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

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

This case 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 02april2024 it was reported to parcus that during a rotator cuff shoulder procedure on a 68-year-old male patient of unknown demographics the suture anchor broke upon entry of the patient's bone.There was no report of any defect with the device or its packaging prior to use of the anchor.There was no negative impact to the patient.It was not reported how the procedure was completed.There was no significant delay to the procedure reported.Additional information was solicited.

Manufacturer Narrative

This case 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.The reported event is not confirmed.The product was not available for analysis.Additional information was not provided upon request.A review of the batch record was performed.There was no nonconformances related to the reported event in the batch record.The lot was manufactured and released per applicable procedures and specifications.A three year retrospective review of all nonconformances was performed for this product.There was no nonconformances for the 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 (b)(6) 2024 it was reported to parcus that during a rotator cuff shoulder procedure on a 68-year-old male patient of unknown demographics the suture anchor broke upon entry of the patient's bone.There was no report of any defect with the device or its packaging prior to use of the anchor.There was no negative impact to the patient.It was not reported how the procedure was completed.There was no significant delay to 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: keith kelly ; 6423 parkland drive; sarasota, FL 34243
• MDR Report Key: 19153270
• MDR Text Key: 341581650
• Report Number: 3007319107-2024-00006
• 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: 11126T
• Device Lot Number: 16186
• 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
• Patient Age: 68 YR