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

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
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 9/15/2023, it was reported by a sales representative via phone that an ar-1540bc biocomposite-tenodesis screw 4 x 10 mm had an issue.During a carpal metacarpal arthroplasty procedure on (b)(6) 2023, when the surgeon was trying to implant the screw, it was not as tight of a fit as preferred, and the device would not seat correctly.The screw was removed in one piece, nothing broke inside the patient, and a mini tightrope implant system with an unknown part and lot number was used to complete the procedure successfully.There was no case delay and no harm to the patient.The screw was discarded by the facility, no pictures were taken.This occurred during use with no patient harm.
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 of the device due to improper bone preparation.Per dfu-0111-7 at revision 0.G.Precautions.4.Bio-tenodesis screw only: use the appropriate size arthrex drill to create a pilot hole in the bone.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17920628
• Report Number: 1220246-2023-08163
• Device Sequence Number: 6671924
• Product Code: HWC
• UDI-Device Identifier: 00888867018709
• UDI-Public: 00888867018709
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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): 02/27/2025

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 Expiration Date: 04/30/2025
• Device Model Number: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1540BC
• Device Lot Number: 15097879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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