MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® TROCH NAIL, Ø10MMX20CMX125°; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® TROCH NAIL, Ø10MMX20CMX125°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 5/5/2023, it was reported by a sales representative via email that a 1030-200 trochanteric nail broke about six weeks after being implanted.The surgeon performed a revision surgery and had the trochanteric nail removed.Additional information received on 5/5/2023: per the sales representative, on (b)(6) 2022, the patient underwent surgery in which a 100mm lag screw, a 5.0mm by 38mm distal screw, and a 1030-200 trochanteric nail were implanted.At the time, the case was completed successfully without any issues.Six months later, the 1030-200 trochanteric nail broke, and the patient undergoes revision surgery on (b)(6) 2023 to have everything removed.The revision surgery was completed with a long nail.
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
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged 1030-200, serial number (b)(6), was received for investigation.No functional test for the trochanteric nail that arrived broken in half for evaluation.The returned trochanteric nail was visually inspected.It was noted that the device was broken into two pieces at the proximal end of the second hole diameter.The more in-depth visual evaluation found that the slot lost geometry; it was damaged.Damaged was also observed on hex threaded for matting parts.It was observed that a piece of material was obstructing the inside diameter hole that pass through the entire part.The visual inspection also noted severe signs of wear on the device and many scratches and dents throughout the nail body.The most likely cause of the reported failure is a patient-specific event.

• Brand Name: GALILEO® TROCH NAIL, Ø10MMX20CMX125°
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17029843
• Report Number: 1220246-2023-06808
• Device Sequence Number: 6973507
• Product Code: HSB
• UDI-Device Identifier: 00848665014631
• UDI-Public: 00848665014631
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: GALILEO® TROCH NAIL, Ø10MMX20CMX125°
• Device Catalogue Number: 1030-200
• Device Lot Number: 212801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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