MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MINI BC PUSHLOCK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTURE ANCHOR, MINI BC PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a small surgery the implant broke during insertion.All parts were retrieved.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
Corrections: d2a, d2b.Additional information: d9, g3, h3, h6.The complaint allegation was not confirmed.No evidence of the implant being broken was received.One unpackaged ar-8825bc-1 batch 15346888 was received for evaluation.Visual inspection found that the screw/implant was not returned.No damage to the tip or shaft was identified.Functional testing was performed by moving the inner and outer shafts, looking for resistance.No issues were found.The most likely cause of the reported failure is a user error, which includes misaligned insertion and/or prying or levering the device with excessive force during use, which ultimately damages the device.

• Brand Name: SUTURE ANCHOR, MINI BC PUSHLOCK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 21949886
• Report Number: 1220246-2025-01856
• Device Sequence Number: 12961849
• Product Code: MBI
• UDI-Device Identifier: 00888867247918
• UDI-Public: (01)00888867247918(11)241112(17)261031(10)15346888
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063479
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: SUTURE ANCHOR, MINI BC PUSHLOCK
• Device Catalogue Number: AR-8825BC-1
• Device Lot Number: 15346888
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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