MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, MPFL, TIGHTROPE; BONE FIXATION SCREW/PLATE

Model Number	IMPL SYS, MPFL, TIGHTROPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06/28/2024, a sales representative via (b)(4) reported that an ar-1360tr-bc mpfl implant system, 3.9 bc swivelock anchor broke upon insertion on a patient with hard bone.The broken anchor was removed entirely with no delay in the case.Another complete kit was opened because no individual anchors were available for backup.It was stated the surgeon followed the technique and was not content that the kit did not contain a tap or an option for a larger drill.This was discovered during an mpfl procedure on (b)(6) 2024, with no reported 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 excessive force being used during insertion of the implant.

• Brand Name: IMPL SYS, MPFL, TIGHTROPE
• 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: jared engle ; 8009337001
• MDR Report Key: 19784180
• Report Number: 1220246-2024-06826
• Device Sequence Number: 12829262
• Product Code: HWC
• UDI-Device Identifier: 00888867354074
• UDI-Public: 00888867354074
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• 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): 06/13/2025

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: IMPL SYS, MPFL, TIGHTROPE
• Device Catalogue Number: AR-1360TR-BC
• Device Lot Number: 15226043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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: Male