MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BIO-COMP SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 4.75MM BIO-COMP SWVLK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, 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.
Event or Problem Description
On 1/18/2023, it was reported by an arthrex employee via email that an ar-1400tb bio-interference screw full thread, an ar-1588t acl tightrope, (3) ar-2324bcc-2 bio composite swivelock, (3) ar-4500 meniscal cinch, (4) ar-7200 fiberwire, and (2) ar-7237 fibertape were all implanted in the patient.This acl and ligament procedure took place on (b)(6) 2023.Patient developed an infection post operative and patient remains admitted to the hospital for treatment.No further information has been provided at this time.Additional information received on 5/15/2024: the patient has not undergone revision surgery, and no further information has been received regarding this incident.
Additional Manufacturer Narrative
Additional information: since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned, photos, or any documentation provided, the reported event is not confirmed.The most likely cause of this failure is attributed to a patient's infection reaction.

• Brand Name: DBL LOADED 4.75MM BIO-COMP SWVLK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19530143
• Report Number: 1220246-2024-05698
• Device Sequence Number: 7604434
• Product Code: MAI
• UDI-Device Identifier: 00888867097995
• UDI-Public: 00888867097995
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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 Expiration Date: 04/30/2026
• Device Model Number: DBL LOADED 4.75MM BIO-COMP SWVLK
• Device Catalogue Number: AR-2324BCC-2
• Device Lot Number: 14962105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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