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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11-dec-2025, a facility representative reported via (b)(4) that an 0826-000 impactor pad broke while the surgeon was trying to remove it to get better visualization on the lateral x-ray to verify pin placement during a case.There were no adverse events, and the case was finished with no issues.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged 0826-000, impactor pad, batch 210508, was received stuck to a 1267-100 radiolucent targeting arm (batch 212569).Visual inspection noted that the 0826-000 impactor pad was stuck to the grommet of the 1267-100 radiolucent targeting arm and could not be detached.Functional testing could not be performed because the devices were inseparable.The most likely cause of the reported failure is attributed to use-related factors, including wear-and-tear damage and excessive mechanical forces applied to the impactor pad in the field over time.The manufacturing date for the targeting arm is november 2021.Refer to the investigation photos.The complaint allegation is confirmed.

• 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: 23943465
• Report Number: 1220246-2026-00010
• Device Sequence Number: 12720242
• Product Code: HSB
• UDI-Device Identifier: 00848665002805
• UDI-Public: (01)00848665002805(11)211108(10)210508
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/12/2026

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: 210508
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown