MAUDE Adverse Event Report: ARTHREX, INC. DISP INSTR. KIT FOR TENO SCRW; POLYETHYLENE SYNTHETIC SUTURE

Model Number	DISP INSTR. KIT FOR TENO SCRW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2023
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.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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-1676ds bio-tenodesis¿ disposable kits driver tip broke off inside the patient.This occurred during a fhl tendon transfer on (b)(6) 2023, once the surgeon had drilled through the bone the device did not look right.The end looked smaller than normal.An x-ray was taken and it appeared as if the eyelet was cut out into the tip of the drill bit that broke in the bone.The fragment remains in the patient.Case was completed using another ar-1676ds bio-tenodesis¿ disposable kit.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation was confirmed based on the customer¿s attached x-ray (case (b)(4) customer x-ray.Jpg), which displays a piece of an alleged ar-1676ds broken.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 concluded that the most likely cause of the reported and observed failure is user error.Specifically, the error involved improper bone preparation, misaligned insertion, or prying/leveraging the device during insertion.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.

• Brand Name: DISP INSTR. KIT FOR TENO SCRW
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 18104095
• Report Number: 1220246-2023-08653
• Device Sequence Number: 14841873
• Product Code: GAT
• UDI-Device Identifier: 00888867020801
• UDI-Public: 00888867020801
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K041553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: DISP INSTR. KIT FOR TENO SCRW
• Device Catalogue Number: AR-1676DS
• Device Lot Number: 15087622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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