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	03/09/2025
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 03/11/2025, it was reported by a sales representative via (b)(4) that an 0826-000 impactor pad had the threads damaged the 1268-100 130° radiolucent targeting arm.There was no patient effect.This was discovered during a hip fracture procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Visual inspection noted that the threads at the distal end of the shaft of the impactor pad had stripped and chipped.Laser marks are faded.Functional testing was performed, and the device did not work as required due to the damage to the threads.The most likely cause of the reported failure is user error, which can be attributed to misaligned insertion and/or excessive force used during insertion of the mating part.

• 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: 21746351
• Report Number: 1220246-2025-01163
• Device Sequence Number: 13134599
• Product Code: HSB
• UDI-Device Identifier: 00848665002805
• UDI-Public: (01)00848665002805(11)221216(10)220991
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 05/19/2025

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: 0826-000
• Device Lot Number: 220991
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown