MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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
On 2nd september 2024, it was reported by an arthrex employee via email that for an ar-1320bcnf, suture anchor, micro biocomposite suturetak® 2.4 x 6.5 mm with 2-0 fiber wire® with two taper point needles, the anchor was broken during insertion.This was detected during repair of anterior talofibular ligament injury of ankle joint surgery on (b)(6) 2024.A 2.0mm drill head from ar-1320dsc kit was used to prepare bone socket.The end of the anchor broke during insertion.Procedure was completed successfully with no patient harm by using another new ar-1320bcnf instead.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1320bcnf batch 15190815 was received for investigation.The visual evaluation revealed that the bio screw was damaged.Additionally, the threading was damaged.A functional testing was not performed due to the damaged to the device.The reported failure is most likely due to user error, specifically from applying excessive force while using the device.

• Brand Name: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• 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: 20225782
• Report Number: 1220246-2024-07651
• Device Sequence Number: 3393582
• Product Code: MAI
• UDI-Device Identifier: 00888867009813
• UDI-Public: 00888867009813
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140855
• 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): 02/03/2025

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 MICROBIO-COMP S-TAK 2.4X 6.5MM
• Device Catalogue Number: AR-1320BCNF
• Device Lot Number: 15190815
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• 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