MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH HIP BIO-COMP P-LCK 2.9X 15.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH HIP BIO-COMP P-LCK 2.9X 15.5MM
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 hip surgery the tip of 5 anchors ar-2923bch (lot: 15349271) broke off during insertion.All fragments were retrieved from the patient.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-1923bch, pushlock®, batch 15349271, was received for evaluation.- upon visual inspection, it was noted that the device was returned without the anchor.- functional testing could not be performed due to the damage to the tip.- the most likely cause for the reported failure can be attributed to is misuse due to misaligned insertion and prying/leveraging the device during use.- the complaint allegation is confirmed.- refer to the investigation photos.

• Brand Name: SUTR ANCH HIP BIO-COMP P-LCK 2.9X 15.5MM
• 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: 22707698
• Report Number: 1220246-2025-03240
• Device Sequence Number: 9759670
• Product Code: MAI
• UDI-Device Identifier: 00888867023031
• UDI-Public: (01)00888867023031(11)241118(17)281031(10)15349271
• 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
• Report Date (Section B): 10/07/2025

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: SUTR ANCH HIP BIO-COMP P-LCK 2.9X 15.5MM
• Device Catalogue Number: AR-1923BCH
• Device Lot Number: 15349271
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown