MAUDE Adverse Event Report: Arthrex, Inc. BIO-COMP SITE P-LCK 2.9X 15.5; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SITE P-LCK 2.9X 15.5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/12/2026
Type of Reportable Event	Serious Injury

• Brand Name: BIO-COMP SITE P-LCK 2.9X 15.5
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50948152
• Report Number: 1220246-2026-04966
• Device Sequence Number: 10446307
• Product Code: MAI
• UDI-Device Identifier: 00888867023024
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 SITE P-LCK 2.9X 15.5
• Device Catalogue Number: AR-1923BC-1
• Device Lot Number: 15522532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown