MAUDE Adverse Event Report: ARTHREX, INC. DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
Medical Device Problem Codes	Positioning Failure (1158); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a patient's mother via phone that the patient had suffered an injury to both ankles while playing soccer.On (b)(6) 2023, the patient underwent surgery to repair the injuries on both ankles using multiple ar-8990st fibertak dx and ar-8990st-2 fibertak dx.Per the mother, the patient had an abnormal recovery, and after x-rays and ct scans, it was determined the fibertak suture anchors on the right ankle were mispositioned.The patient's mother called to inquire if the implants and absorption rate are absorbable.No further information has been reported.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error.Per dfu-0054-eo revision 5, g.Precautions 6.Suturetak and fibertak suture anchors only: 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.

• Brand Name: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 17713617
• Report Number: 1220246-2023-07833
• Device Sequence Number: 2251378
• Product Code: MBI
• UDI-Device Identifier: 00888867377370
• UDI-Public: 00888867377370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• Device Catalogue Number: AR-8990ST-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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