MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the shoulder arthroscopy that the metal tip detached from the device after the second or third strike with the hammer.After retrieving the metal tip, the surgeon was able to reattach it to the device, repeat the process and implant the anchor.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• 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: 22729444
• Report Number: 1220246-2025-03281
• Device Sequence Number: 13009243
• Product Code: MAI
• UDI-Device Identifier: 00888867022904
• UDI-Public: (01)00888867022904(11)250324(17)290228(10)15408197
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K082810
• 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
• Report Date (Section B): 08/06/2025

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: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Device Catalogue Number: AR-1922BCM-1
• Device Lot Number: 15408197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown