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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th august 2025, it was reported by an arthrex's employee via email that for 1 unit of ar-1923bc, suture anchor, biocomposite pushlock® 2.9 x 15.5 mm, its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1923bc.There was no patient harm, and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was substantiated.Observed damage to the eyelet and shaft is indicative of potential excessive force applied during use.One unpackaged ar-1923bc batch 15334661 was received for evaluation.Visual inspection revealed that the eyelet was bent, indicating that excessive force had been applied to it.The broken anchor pieces were not received for evaluation.A functional test was performed by moving the inner shaft, and no resistance was noted; however, it was noted that the outer shaft felt loose.The most likely cause of the reported failure was user error, including improper bone preparation and/or incorrect insertion angle.

• 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: 22906578
• Report Number: 1220246-2025-03669
• Device Sequence Number: 8932161
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: (01)00888867023017(11)241021(17)280930(10)15334661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/17/2025

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: 15334661
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown