MAUDE Adverse Event Report: ARTHREX, INC. ES¿ TROCH NAIL, RIGHT, Ø11MMX39CMX125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	ES¿ TROCH NAIL, RIGHT, Ø11MMX39CMX125°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that a patient underwent surgery due to an intertrochanteric fracture in (b)(6) 2023.On 10/4/2023, the sales representative was made aware via phone that the lag screw implanted in the patient broke.The patient will undergo revision surgery.No further information has been provided.Additional information received on 10/13/2023: in (b)(6) 2023, the patient underwent surgery in which a 1023-395 trochanteric nail and a 1099-095 lag screw were implanted.On (b)(6) 2023, the patient felt pain while walking.A revision surgery took place on 10/6/2023 to remove the troch nail and lag screw.During the removal of the lag screw, it was noticed that it had scratches distal to the threads.The case was completed as a total hip arthroplasty procedure.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, abrasion marks were noted inside the major hole, and chips were observed around the edges of the threaded area of the es¿ trochanteric nail, right, 11mm x 39cm x 125º.No broken parts on the device were observed.Functional testing was performed with a telecosping lag screw and 5.00 mm captured cortical screw, revealing that they went through the nail without an issue.The most likely cause of this failure is attributed to user error.The most likely cause of this failure is attributed to user error.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Complaint allegation is not confirmed.

• Brand Name: ES¿ TROCH NAIL, RIGHT, Ø11MMX39CMX125°
• 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: emily shafer ; 8009337001
• MDR Report Key: 18029143
• Report Number: 1220246-2023-08437
• Device Sequence Number: 17630860
• Product Code: HSB
• UDI-Device Identifier: 00848665014532
• UDI-Public: 00848665014532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ES¿ TROCH NAIL, RIGHT, Ø11MMX39CMX125°
• Device Catalogue Number: 1023-395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown