MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP-SITE P-LCK 2.9X15.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
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 an arthroscopic shoulder surgery the anchor broke.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.Complaint allegation is confirmed.One unpackaged ar-1923bc serial/batch number (b)(6) was received for evaluation.Functional testing was not performed as the device was broken when received.Visual inspection revealed that the inner shaft tip was bent.The reported failure anchor was not received for evaluation.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The outer shaft outside diameter was measured by drawing c6878 at revision 6 ø 062 ±.001, resulting in 0.062.The shaft is in tolerance by the drawing specifications.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.According to direction for use.Dfu-0087-eor3_fmt_en.G.Precautions.3.Make sure to use the recommended drill bit or punch to create the bone socket.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.5.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.8.Self-punching pushlock and swivelock suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.

• Brand Name: BIO-COMP-SITE P-LCK 2.9X15.5MM
• 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: 20260782
• Report Number: 1220246-2024-07761
• Device Sequence Number: 8722702
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: (01)00888867023017(11)240123(17)271231(10)15197029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173240
• 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): 01/20/2025

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 2.9X15.5MM
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 15197029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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