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	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
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
On 30th april 2025, it was reported by an arthrex employee via email that for 2 units of ar-1923bc-1, suture anchor, biocomposite pushlock® 2.9 x 15.5 mm, the anchors broke during insertion process.Sockets had been drilled and anchor malleted down to bone, then anchors broke into several pieces while final malleting of anchor into socket.This was detected during use in a posterior shoulder labral repair for instability procedure on 29th april 2025.The procedure was completed successfully as they changed to using peek pushlock anchors instead of biocomposite and ensured that drill holes were to correct depth.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed due to the device not being returned and no photos of the reported failure being provided.Based on the information provided which may include the event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misaligned insertion, and/or prying/leveraging of the device during insertion.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22037259
• Report Number: 1220246-2025-02075
• Device Sequence Number: 8436890
• Product Code: MAI
• UDI-Device Identifier: 00888867023024
• UDI-Public: (01)00888867023024(11)240902(17)280831(10)15310337
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101679
• 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): 08/27/2025

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 2.9X 15.5
• Device Catalogue Number: AR-1923BC-1
• Device Lot Number: 15310337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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
• Patient Sex: Unknown