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

Model Number SUTURE ANCHOR, BIO-CORKSCREW FT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Osteolysis (2377)

Event Date 06/22/2023

Event Type  Injury  

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 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.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• Type of Device: 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
• MDR Text Key: 337108502
• Report Number: 1220246-2024-01333
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023352
• UDI-Public: 00888867023352
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other