MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/16/2022
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 (b)(6) 2023, it was reported by a facility representative via email that a patient underwent a right knee arthroscopy and aclr with allograft procedure on 12/16/2022.On (b)(6) 2022, the patient started to experience itchiness and small hives forming on the right leg near the scar.By (b)(6) 2022, the patient noticed redness around the incision site.The patient informed the surgeon and was given antibiotics and benadryl.By (b)(6) 2023, the issue was resolved and the skin looked normal.On (b)(6) 2023, the patient noticed swelling and redness at the incision site.The surgeon prescribed antibiotics but, eventually, an abscess-like bump formed in the leg, which was drained in an in-office procedure.Later, the abscess re-formed and burst on its own, and another round of antibiotics was prescribed.The patient underwent i &d.As of (b)(6) 2023, the patient is still experiencing redness, swelling, pitting edema in the right leg, abscess, drainage, and wound dehiscence.The patient has had bloodwork and cultures to find the reaction cause.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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(s) of the reported failure can be attribute to patient specific event.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: Ø9X 20MM BC IF SCRW, VENTED
• 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: emily shafer ; 8009337001
• MDR Report Key: 18181851
• Report Number: 1220246-2023-08831
• Device Sequence Number: 7717027
• Product Code: MAI
• UDI-Device Identifier: 00888867276970
• UDI-Public: 00888867276970
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: Ø9X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-09
• Device Lot Number: 15076394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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