MAUDE Adverse Event Report: ARTHREX, INC. IMPACTOR PAD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	IMPACTOR PAD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
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 12/26/2024, it was reported by a sales representative via (b)(4) that an 1239-100 insertion guide, and 1255-300 tibial insertion guide malfunctioned.This occurred during an im nail tibia procedure the tibial nail connection piece broke upon impacting the nail down.There was no additional information provided, and additional information has been requested.Additional information was provided on 12/31/2024, where the sales representative stated that upon impaction of the tibial nail, the 0837-000 strike plate broke off and the threads were cold welded into the connecting piece.The 1239-100 knob in which you connect the carbon jig to is also cold welded into the 1255-300 inserter.The patient was relatively young with decently good bone quality.The surgeon completed final nail insertion by impacting directly on the tibial nail jig.There was no delay in the procedure and no additional anesthesia time was needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged 0837-000 impactor pad batch/serial number (b)(6) was received for evaluation.Upon visual inspection, it was noted that the threaded tip was broken off.The laser marks on the shaft are faded and scratches and marks were noted in the body of the device.Functional testing was not performed as the device was damaged.The most probable reason for the reported malfunction is wear and tear over repetitive use.The device manufacturing date is july 19, 2022.

• Brand Name: IMPACTOR PAD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 21200390
• Report Number: 1220246-2025-00022
• Device Sequence Number: 8302366
• Product Code: HSB
• UDI-Device Identifier: 00848665013559
• UDI-Public: (01)00848665013559(11)220719(10)220727
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• 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): 05/28/2025

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: 220727
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown