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

Model Number	IMPACTOR PAD
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 (b)(6) 2026, a facility representative reported via (b)(4) that the 0826-000 impactor pad became cold-welded to the 1268-100 130-degree radiolucent targeting arm, and upon removal, the metal fitting inside the targeting arm came out with the impactor pad, rendering both unusable.The damage that was incurred perhaps added 5 minutes onto the case and additional anesthesia, but no direct harm was done to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged 0826-000 impactor pad, batch 220991, was received for investigation.Visual inspection identified multiple forms of damage, including: surface damage impactor pad stripped threads chipping discoloration functional testing noted resistance when locking and unlocking into a known-good targeting arm.The most likely cause for the reported failure can be attributed to wear and tear damage incurred over time.The manufacturing date is 2022.The complaint allegation is confirmed.Refer to the investigation photographs.

• 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: 24178209
• Report Number: 1220246-2026-00313
• Device Sequence Number: 9578594
• Product Code: HSB
• UDI-Device Identifier: 00848665002805
• UDI-Public: (01)00848665002805(11)221216(10)220991
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 03/13/2026

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: 0826-000
• Device Lot Number: 220991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown