MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/22/2023
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that a patient suffered from an osteolysis after the usage of an arthrex biocomposite screw.No further information received.*** update dw 26-feb-2024: further information was provided that the first arthrex employee was made aware of this issue on 22nd june 2023.The initial surgery was performed on (b)(6) 2020 with an ar-2323bcc and ar-1927bcf.The patient returned due to pain for a mri in (b)(6) 2023.*** update dw 28-feb-2024: further information were provided that no further treatment was performed due to this issue.
Additional Manufacturer Narrative
The complaint is confirmed based on the mri photo that the customer provided, which displays osteolysis around the implant.The most likely cause for the reported failure can be attributed to a patient-specific event of the immune response allograft tissue and/or a previous history of infection or arthritis of the patient that was not reported due to the patient developing osteolysis.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• 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: 18856245
• Report Number: 1220246-2024-01333
• Device Sequence Number: 8295021
• Product Code: MAI
• UDI-Device Identifier: 00888867023352
• UDI-Public: 00888867023352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• 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): 06/13/2024

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 Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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