MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, BIOCOMPOSITE; BONE FIXATION SCREW/PLATE

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
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 an arthrex employee via email that an ar-1555bc biocomposite-tenodesis screw broke during insertion into the fibula.This was discovered during an anterior talo-fibular ligament reconstruction procedure on (b)(6)/2023.The case was completed using another ar-1555bc biocomposite-tenodesis screw from the same lot number.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided photo.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 improper bone prep and/or misaligned insertion.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16843686
• Report Number: 1220246-2023-06637
• Device Sequence Number: 15170983
• Product Code: HWC
• UDI-Device Identifier: 00888867018853
• UDI-Public: 00888867018853
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051726
• 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): 10/04/2024

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 Expiration Date: 09/30/2025
• Device Model Number: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1555BC
• Device Lot Number: 14271247
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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