MAUDE Adverse Event Report: ARTHREX, INC. T-HANDLE, CANNULATED, LARGE HUDSON; INTRAMED FIXATN ROD AND ACCESS

Model Number	T-HANDLE, CANNULATED, LARGE HUDSON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/24/2024, a sales representative reported via sems- (b)(4) that an 0468-000 t-handle, cannulated, large hudson broke when tightening the troch nail to the jig.There were no pieces breaking off inside the patient.The case was completed successfully, and no further information was provided.A photo is attached.This was discovered during an intertrochanteric fx im nail procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, 0468-000, t-handle hudson, batch 140794, was received for investigation.Upon visual inspection, it was noted that the distal end had circumferential grinding marks on the collar.There were also nicks and evidence that fragments had broken off within the cannulated shaft.Functional testing was not performed due to the damage of the device.The most likely cause of this condition is misuse due to the exerting excessive force/friction during use or insertion.

• Brand Name: T-HANDLE, CANNULATED, LARGE HUDSON
• 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: 19760175
• Report Number: 1220246-2024-06783
• Device Sequence Number: 13008805
• Product Code: LXH
• UDI-Device Identifier: 00848665001969
• UDI-Public: 00848665001969
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/20/2024

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: T-HANDLE, CANNULATED, LARGE HUDSON
• Device Catalogue Number: 0468-000
• Device Lot Number: 140794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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