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

Model Number	DBL LOADED 4.75MM BIO-COMP SWVLK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 Manufacturer Narrative
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.
Event or Problem Description
Additional information received on 5/15/2024: the patient has not undergone revision surgery, and no further information has been received regarding this incident.

• Brand Name: DBL LOADED 4.75MM BIO-COMP SWVLK
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16302970
• Report Number: 1220246-2023-06210
• Device Sequence Number: 6185174
• 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): 06/12/2024

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: 12/31/2025
• Device Model Number: DBL LOADED 4.75MM BIO-COMP SWVLK
• Device Catalogue Number: AR-2324BCC-2
• Device Lot Number: 14894136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown