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	05/27/2025
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 05/27/2025, a facility representative reported via (b)(4) that an 0837-000 impactor pad connection portion of the strike plate broke in the connection portion of the 1255-300 suprapatellar insertion guide.A case was involved, and no patient was affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.Upon visual inspection, it was noted that inside the hole of the insertion guide, the threaded broken tip of the impactor pad returned.Functional testing was not performed due to the device's damage.The most likely cause of the reported failure is user-applied excessive mechanical forces striking against the impactor's square pad surface, misaligned insertion, and/or prying/leveraging the device during insertion.

• 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: 22285262
• Report Number: 1220246-2025-02529
• Device Sequence Number: 12832637
• Product Code: HSB
• UDI-Device Identifier: 00848665039153
• UDI-Public: (01)00848665039153(11)231011(10)231106
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 231106
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown