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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cuff surgery while drilling prehoal to get the anchor down, turning counterclockwise as instructions says but when pulling up the anchor follows along.Two anchors failed and the third one they did not want to keep it.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-1922bcm biocomposite pushlock was received for investigation.Visual evaluation of the returned device noted no apparent issues with the device.Functional testing was performed with a bone block and it was found the device functions as intended as the anchor was able to be set successfully within the bone block.No problem was found with the returned device.Refer to investigation photos.

• 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: 21460460
• Report Number: 1220246-2025-00654
• Device Sequence Number: 7763639
• Product Code: MAI
• UDI-Device Identifier: 00888867022898
• UDI-Public: (01)00888867022898(11)240603(17)280531(10)15257198
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 08/11/2025

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
• Device Lot Number: 15257198
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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