MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 labrum refixation surgery the implant did not separate from the driver.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
Additional information: d9, g3, h3, h6 one unpackaged ar-2923bc pushlock®, batch 15378521, was received for investigation.Visual inspection noted that the eyelet and anchor were not returned for evaluation.Functional testing was not performed due to the damage to the device.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.Most likely cause can be attributed to misuse, which may include: improper bone preparation misaligned insertion the complaint allegation is confirmed.Refer to the attached investigation photos.
Additional Manufacturer Narrative
Additional information: g3, h3.One unpackaged ar-2923bc pushlock®, batch 15378521, was received for investigation.Visual inspection noted that the eyelet and anchor were not returned for evaluation.Functional testing was not performed due to the damage to the device.The method used to prepare the bone, as well as the bone quality encountered during the procedure, was not provided.Most likely cause can be attributed to misuse, which may include: improper bone preparation.Misaligned insertion.The complaint allegation is not confirmed, as there was no clear photographic/video evidence or operative documentation of non-separation at the time of use.Refer to the attached investigation photos.

• Brand Name: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• 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: 23313172
• Report Number: 1220246-2025-04655
• Device Sequence Number: 14903347
• Product Code: MAI
• UDI-Device Identifier: 00888867099203
• UDI-Public: (01)00888867099203(11)250127(17)261231(10)15378521
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/19/2026

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: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC
• Device Lot Number: 15378521
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/19/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/02/2026; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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