MAUDE Adverse Event Report: ARTHREX, INC. IMPACTOR PAD; INTRAMED FIXATN ROD AND ACCESS

Model Number	IMPACTOR PAD
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
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 (b)(4) 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged 0837-000, impactor pad, batch number: 212459, was returned for investigation.Visual evaluation noted significant strike marks on the proximal end of the device.Additionally, the threads, where the device connects, broke off inside the 1255-300/ batch 212471a.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.The surgical technique states the following: "caution: take care not to strike the targeting module with the slotted mallet.Avoid excessive force when inserting the nail.If the nail jams in the canal while inserting, extract it and choose the next-smaller diameter nail or prepare the canal appropriately.".

• Brand Name: IMPACTOR PAD
• 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: 21085140
• Report Number: 1220246-2025-09233
• Device Sequence Number: 15550091
• Product Code: HSB
• UDI-Device Identifier: 00848665013559
• UDI-Public: (01)00848665013559(11)210825(10)212459
• 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): 05/29/2025

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: IMPACTOR PAD
• Device Catalogue Number: 0837-000
• Device Lot Number: 212459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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