MAUDE Adverse Event Report: ARTHREX, INC. ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130°; INTRAMED FIXATN ROD AND ACCESS

Model Number	ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130°
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 09/03/2024, it was reported by a sales representative via (b)(4) that a 5033-100 capturing rod assembly was cold-welded with the screw.This occurred during a revision troch nail procedure when the surgeon removed our troch nail and implanted a synthes nail when the galileo capturing rod cold welded to the screw upon removal.
Additional Manufacturer Narrative
No allegations were identified against the 1058-395 es¿ trochanteric nail, left, 11mm x 39cm x 130º serial/batch number 211326; however, the returned device was damaged.One unpackaged 1058-395 es¿ trochanteric nail, left, 11mm x 39cm x 130º serial/batch number 211326 was received for evaluation.Visual inspection revealed scratches and geometry loss due to a bent in the hole where the lag screw is set.The observed damage is most likely caused by excessive force application or misalignment during removal.A damaged thread was also noted on the connector hole at the proximal end.This was most likely caused by user error.When two devices are intended to be threaded/mated together, ensure they are fully engaged before use.
Event or Problem Description
On 9/10/2024 additional information was received by a sales representative via email who stated that the procedure performed was a subtrochanteric hip fracture.The lag screw broke in the patient's femoral head.The date of the initial procedure was (b)(6) 2024.A picture attached shows all the parts used in the initial procedure.An arthrex rep was present.A standard 10.3 drill in the torch nail set was used to prepare the bone socket for insertion.All fragments were retrieved from the patient.To complete the procedure, a standard removal instrumentation for the lateral body of the lag screw.The surgeon used a conical extractor from the aos 7.0 screw set and removed the purple broken screw threads halfway and then bent a 2.0 k wire into the cannula of the screw and removed from the femoral head.It was unknown if there were delays or if additional anesthesia was needed.

• Brand Name: ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130°
• 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: 20522263
• Report Number: 1220246-2024-08233
• Device Sequence Number: 9044265
• Product Code: HSB
• UDI-Device Identifier: 00848665015164
• UDI-Public: (01)00848665015164(11)210507(10)211326
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/24/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130°
• Device Catalogue Number: 1058-395
• Device Lot Number: 211326
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 09/10/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/05/2024; 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown