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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
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
It was reported that during a labral repair surgery when removing the implant from the packaging, the tip of the anchor did not hold and the anchor could not be inserted.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.Update avoe 09-jun-2025 according to the information from the hospital, the surgeon tried to insert the anchor, but it was not possible.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1923bc-1, suture anchor, biocomposite pushlock® 2.9 x 15.5 mm, batch number 15276388, was received for investigation.Visual inspection noted that only the driver was returned for evaluation.The implant and eyelet were detached.Functional testing could not be performed due to the damage to the device.The most likely cause is misaligned insertion or prying/leveraging the device during use.Complaint allegation is confirmed.The allegation of an out-of-box failure cannot be substantiated, as the device was used prior to return and was not received in a complete condition for thorough investigation.

• 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: 22310628
• Report Number: 1220246-2025-02637
• Device Sequence Number: 8655352
• Product Code: MAI
• UDI-Device Identifier: 00888867023024
• UDI-Public: (01)00888867023024(11)240620(17)280531(10)15276388
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 09/09/2025

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: 15276388
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown