MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,BIO-COMP S-TAK
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
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 12/11/2023, it was reported by an arthrex subsidiary employee that an ar-1934bcf-2-1 biocomposite suturetak anchor broke during insertion.The case was completed by removing all the broken fragments and using another ar-1934bcf-2-1 biocomposite suturetak.This was discovered during a ligament talus reinforced fixed suture procedure on (b)(6) 2023.The procedure was delayed twenty minutes; however, no additional anesthesia was needed, and the patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-1934bcf-2-1, sutr anch, bio-comp s-tak serial/batch number (b)(6), was received for investigation.Visual inspection noted that the anchor of the device was damaged/broken.The most likely cause can be attributed to improper bone preparation; misaligned insertion; or prying/leveraging the device during use.Dfu-0054-eo_5: g; precautions; 6 states the following: "anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.".

• Brand Name: SUTR ANCH,BIO-COMP S-TAK
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18452510
• Report Number: 1220246-2024-00122
• Device Sequence Number: 20606041
• Product Code: MAI
• UDI-Device Identifier: 00888867097018
• UDI-Public: 00888867097018
• 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): 08/23/2024

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 Model Number: SUTR ANCH,BIO-COMP S-TAK
• Device Catalogue Number: AR-1934BCF-2-1
• Device Lot Number: 15022021
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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