MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP-SITE P-LCK 2.9X15.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during the arthroscopic labral repair, the anchor broke inside the patient.Some of the fragments were removed from the patient, but part of them remained inside the patient.Per complaint reporter there was no harm for patient, operator or third party.Update 13-feb-2026 - further information was received: it was reported that during the shoulder bankart/ slap repair, that one anchor did not break but the eyelet broke off in the socket and remained inside the patient.The second anchor (same part number and batch) broke into two pieces but all fragments were retrieved from the patient.The patient suffered a glenoid fracture during implantation of the anchors.The small glenoid fracture did not require treatment.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique and no second surgery is planned.

• Brand Name: BIO-COMP-SITE P-LCK 2.9X15.5MM
• 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: 24344432
• Report Number: 1220246-2026-00604
• Device Sequence Number: 9423736
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: (01)00888867023017(11)250113(17)281231(10)15371898
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BIO-COMP-SITE P-LCK 2.9X15.5MM
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 15371898
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown