MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® TROCH NAIL, Ø10MMX20CMX130°; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® TROCH NAIL, Ø10MMX20CMX130°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 8/16/2023, it was reported by a sales representative via email that a patient underwent revision surgery on (b)(6) 2023 due to a broken troch nail.The lag screw protruded laterally out of the nail, and some thread we're sheared off the lag screw.The original procedure was performed on (b)(6) 2022.No further information has been reported.Additional information received on 8/18/2023: both procedures were performed at the same facility but by different surgeons.The revision surgery was completed by removing the 1040-200 trochanteric nail, 1192-105 telescoping lag screw left, and 8001-040 captured cortical screw, and by doing a hip hemiarthroplasty.There were no arthrex parts used in the revision surgery.
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
The complaint is not confirmed.One unpackaged 1040-200 galileo troch nail, ø10mmx20cmx130° serial/batch number: (b)(6), was received for investigation.Upon visual evaluation, it was found multiple scratches at the outside diameter at the proximal end and in the lateral hole.However, it was not observed broken pieces on the galileo troch nail.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is due to not following the surgical technique.Per dfu-0374 at revision 0.G.Precautions.2.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.Or contact your arthrex representative for an onsite demonstration.The trochanteric nail system includes the trochanteric nail, es trochanteric nail, lag screws, anti-rotation screws, cortical screws, and end caps.These are open reduction and internal fixation devices.The proximal screw holes in the es and long nails have 10° of anteversion.One of the proximal screw holes accepts a 10.5 mm solid lag screw, 10.5 mm solid locking lag screw, or side specific 10.5 mm telescoping lag screw, which are used to lag together fractures of the proximal femur.To help minimize lag screw back out, the solid locking lag screw, telescoping lag screw, and the side-specific telescoping lag screw can be locked into the nail intraoperatively.Both the telescoping lag screw and the side-specific telescoping lag screw allow the threads to collapse unidirectionally up to 10 mm within the barrel, with the exception of the 85 mm length (7 mm collapse) and 90 mm length (9 mm collapse).Refer to the trochanteric nail system surgical technique for additional information.

• Brand Name: GALILEO® TROCH NAIL, Ø10MMX20CMX130°
• 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: emily shafer ; 8009337001
• MDR Report Key: 17719546
• Report Number: 1220246-2023-07841
• Device Sequence Number: 7022356
• Product Code: HSB
• UDI-Device Identifier: 00848665014778
• UDI-Public: 00848665014778
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/06/2024

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: GALILEO® TROCH NAIL, Ø10MMX20CMX130°
• Device Catalogue Number: 1040-200
• Device Lot Number: 212791
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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