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

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/13/2022, it was reported by an arthrex employee via email that an ar-1540bc bio-composite-tenodesis screw broke during insertion.Surgeon was able to retrieve all broken fragments.This was discovered during an ankle side instability procedure on (b)(6) 2022.
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
The complaint is confirmed based on the customer-provided photo, which identifies the broken ar-1540bc screw.However, as the device was not returned for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• Common Device Name: SCREW, FIXATION, BONE
• 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: 14829167
• Report Number: 1220246-2022-05145
• Device Sequence Number: 4833127
• Product Code: HWC
• UDI-Device Identifier: 00888867018709
• UDI-Public: 00888867018709
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 07/01/2022

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: 12/31/2022
• Device Model Number: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1540BC
• Device Lot Number: 12605572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/01/2022
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown