MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
It was reported that after a rotator cuff repair surgery the patient has an infection.Due to the infection the implanted items will be removed in revision surgery on (b)(6) 2023.The following devices were used or implanted in the initial surgery: ar-6530-1 lot: 829187258, ar-13995n-1 lot: 15068024, ar-1927bct-1 lot: 14146766, ar-2324bcm-1 lot: 15046069.Update swit 27-jun-2023: the initial surgery was performed last week.The infection was observed during the weekend (on (b)(6) 2023).The intervention is planned for on (b)(6) 2023.The surgeon is planning to remove everything without replacing implants.Update swit 30-jun-2023: the implants were successfully removed during revision surgery.They are awaiting the results of the bacteriological sample.The patient will receive an antibiotic therapy and once the infection has been resolved, he will wear stocks.
Additional Manufacturer Narrative
Additional information: d6b, g3, h3, h6.Based on the image from the field, it is evident that the device was explanted.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17304400
• Report Number: 1220246-2023-07107
• Device Sequence Number: 6506598
• Product Code: MAI
• UDI-Device Identifier: 00888867098039
• UDI-Public: 00888867098039
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BIO-COMP SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM-1
• Device Lot Number: 15046069
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown