MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-TENOD SCRW W/DISP DRV 6.25X15MM; BONE FIXATION SCREW/PLATE

Model Number	BIO-COMP-TENOD SCRW W/DISP DRV 6.25X15MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
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 11/09/2023, it was reported by an arthrex subsidiary employee via email that an ar-1562cds biocomposite tenodesis screw suture loop broke during insertion.This was discovered during an achilles tendon rupture procedure on (b)(6) 2023.The case was completed using a new product.Additional information received on 11/14/2023: as the ar-1562cds biocomposite tenodesis screw was being inserted, the loop started to break gradually as it was being screwed into the bone hole.All the broken fragments were removed.The case was completed ar-1562cds biocomposite tenodesis screw.The case was not delayed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint cannot be confirmed due to the device being unable to be visually and functionally evaluated.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 of the reported failure is a user error, such as misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.

• Brand Name: BIO-COMP-TENOD SCRW W/DISP DRV 6.25X15MM
• 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: 18271168
• Report Number: 1220246-2023-09192
• Device Sequence Number: 3956191
• Product Code: HWC
• UDI-Device Identifier: 00888867233980
• UDI-Public: 00888867233980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/20/2025

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: BIO-COMP-TENOD SCRW W/DISP DRV 6.25X15MM
• Device Catalogue Number: AR-1562CDS
• Device Lot Number: 215124587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/20/2025
• 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