MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/9/2024, it was reported by a facility representative via email that an ar-2323bcc biocomposite swivelock was implanted in a patient on (b)(6)2024 during an rcr procedure.The patient developed a postoperative infection.No additional information was provided.
Event or Problem Description
Additional information received on 12/19/2024: on (b)(6) 2024, the patient started to experience low-grade fevers and slight redness to the incision site.Fourteen days postoperative, on (b)(6) 2024, the patient had constant aching and throbbing pain.Days later, the patient reported tenderness, pain, low-grade fevers, chills, puffiness, inflamed, redness, and warmth to touch at the incision site.However, there was no drainage from the incision site.The patient also reported weight loss.On (b)(6) 2024, the patient was prescribed cephalexin antibiotic.At one point, the patient reported improvement, but on (b)(6) 2024, the patient complained of worsening achy pain, swelling, tenderness, redness, fevers, chills, warmth to touch, weight loss, and pustule had developed.During a clinical visit on (b)(6) 2024, the patient continued to have the same symptoms; however, no purulence discharge.The patient was given clindamycin.On 12/28/2024, the patient reported a pustule draining reddish-yellow purulent exudate, increased redness, and hot to touch.On (b)(6) 2024, the patient had an incision and drainage procedure.Additional information received on 1/7/2025: as of (b)(6) 2024, the patient finished with physical therapy.The patient's shoulder is doing extremely well with no pain and a good range of motion.The incision has healed well.There are no signs of erythema, warmth, or symptoms of infection.
Additional Manufacturer Narrative
Additional information: b5, g3.
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.

• Brand Name: BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
• 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: 21079820
• Report Number: 1220246-2025-09220
• Device Sequence Number: 8444035
• Product Code: MAI
• UDI-Device Identifier: 00888867026728
• UDI-Public: (01)00888867026728(11)240306(17)280229(10)15216699
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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 SWIVELOCK C, CLD 5.5X19.1MM
• Device Catalogue Number: AR-2323BCC
• Device Lot Number: 15216699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 06/12/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/15/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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