MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø10X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the patient underwent a right acl revision reconstruction with autograft, medial meniscus repair, and partial lateral meniscectomy.It was reported that during the course of the operation, in performing a repair of the medial meniscus, an intra-meniscal repair device called a fiberstitch made by arthrex was used to repair the medial meniscus.During the meniscus repair, a portion of the device broke and was left behind in the patient¿s knee.Also, during this procedure, the surgeon cleared the knee of a previously implanted graft and fiberwire sutures.Between (b)(6) 2021, and (b)(6) 2021, the patient had continuous calls and follow-ups with his physician reporting significant pain.On (b)(6) 2021, an x-ray was taken, which revealed a foreign body inside the right knee.On (b)(6) 2021, a second surgery was performed to remove the foreign body.During the removal procedure, it was noted that the patient had significant synovitis throughout the knee joint with failed medial meniscus repair and a retained device fragment.It was noted that the fragment was 2 cm in length.The medial meniscus was not repaired at this time.The patient has had continued pain, infections, and surgical intervention following the removal.It is unknown if any arthrex devices were involved in surgeries following the (b)(6) 2021, removal.Additional information received 9/8/2023: implant log provided.Devices used in surgery identified as: fiberstitch implant ar-4570 (lot 21j79); fiberstitch implant ar-4570s (lot 20p66); fiberthread biocomposite interference screw ar-4020c-08 (lot 11614673); and fiberthread biocomposite interference screw ar-4020c-10 (lot 13427980).
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.
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: Ø10X 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: 17890061
• Report Number: 1220246-2023-08090
• Device Sequence Number: 12497299
• Product Code: MAI
• UDI-Device Identifier: 00888867276987
• UDI-Public: 00888867276987
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: 05/31/2025
• Device Model Number: Ø10X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-10
• Device Lot Number: 13427980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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