MAUDE Adverse Event Report: ARTHREX, INC. SUPRAPATELLAR INSERTION GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	SUPRAPATELLAR INSERTION GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information: rep stated locking knob was also stuck.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 1255-300, tibial insertion guide, batch number: 212471a, was returned for investigation.Visual evaluation noted signs of wear along the body of the device: fading laser marks, and discoloration.Additionally, part of the threads of the 0837-000, impactor pad, where the device connects, broke off inside the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/10/2024 it was reported by a sales representative via sems-06732154 that an 0837-000 impactor pad and an 1255-300 suprapatellar insertion guide broke.As a nail was being reamed, the jig was hit with the impactor pad and broke off at the attachment to the jig.This was discovered during the procedure.The procedure was completed without any issues and the nail was inserted normally.X-rays were confirmed to make sure no metal pieces were left inside of the body.Procedure was completed as planned with no patient harm.

• Brand Name: SUPRAPATELLAR INSERTION GUIDE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 21085150
• Report Number: 1220246-2025-09234
• Device Sequence Number: 15550092
• Product Code: HSB
• UDI-Device Identifier: 00848665039153
• UDI-Public: (01)00848665039153(11)220328(10)212471A
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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): 02/18/2025

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: SUPRAPATELLAR INSERTION GUIDE
• Device Catalogue Number: 1255-300
• Device Lot Number: 212471A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown