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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.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 5 pushlocks as-2923bc (lot: 14998931) broken off during insertion.All fragments could be retrieved.According to the surgeon no harm for patient, operator or third party occurred.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.The complaint allegation is confirmed.One unpackaged ar-2923bc serial/batch number (b)(6) was received for investigation.Only the eyelet was received for evaluation.The visual evaluation revealed that the eyelet was bent.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion, or excessive forces through leveraging/prying the device.According to dfu-0087 at revision 13.E.Warnings.6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.G.Precautions.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.

• 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: 18904225
• Report Number: 1220246-2024-01465
• Device Sequence Number: 9256301
• Product Code: MAI
• UDI-Device Identifier: 00888867099203
• UDI-Public: 00888867099203
• 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): 12/04/2024

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 Expiration Date: 08/31/2024
• Device Model Number: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC
• Device Lot Number: 14998931
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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