MAUDE Adverse Event Report: ARTHREX, INC. REDUCTION TOOL; INTRAMED FIXATN ROD AND ACCESS

Model Number	REDUCTION TOOL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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 06/28/2024, a sales representative via (b)(4) reported that a 0804-000 reduction tool was bent.The surgeon noticed that the reduction tool they were using to change the position of the ball tip wire was bent and should remain straight and not be easy to bend in the shaft.The representative stated that this is an extensive manual for surgeons to use intramedullary, and any bend in poor bone could cause an iatrogenic fracture.No harm came to the patient; they changed instruments when they noticed the deficiency in the product.This was discovered during a hip fracture procedure (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 0804-000 batch 211858 was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection revealed that the shaft has a significant bend, compromising the device's proper functionality.The most probable cause of the reported and observed failure is the application of excessive force during use.

• Brand Name: REDUCTION TOOL
• 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: 19818654
• Report Number: 1220246-2024-06883
• Device Sequence Number: 20979806
• Product Code: HSB
• UDI-Device Identifier: 00848665002607
• UDI-Public: 00848665002607
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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): 09/27/2024

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: REDUCTION TOOL
• Device Catalogue Number: 0804-000
• Device Lot Number: 211858
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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