MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PROXIMAL FEMUR NAILING SYSTEM (NAIL); INTRAMEDULLARY FIXATION ROD

Catalog Number	PPFL11420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Examination of the production records of the involved nail did not reveal any deviation from specification.The explanted nail was received by the company and examined.The nail has a fracture in the upper third portion of the shaft.Other than that, the surface area of the nail looks intact in macroscopic and microscopic evaluation.Biomechanical testing of the distal portion of the returned nail was performed.The test was successfully completed with the product complying with the requirements.Based on data reported to the company, during insertion of the nail into the bone (highly dense bone) the surgeon had to rotate the nail, and a noise was heard.This might have been the formation of a crack, that might have contributed to nail fracture.It is noted that in the warnings and precautions section of the system instructions for use it is indicated that: "the surgeon should be cautious with limb position changing and/or excessive force exertion while accessories are still connected to the implants, in order to avoid tissue and/or device damage".
Event or Problem Description
The patient was admitted to the hospital due to trauma fracture.A piccolo composite proximal femur nail was implanted.About 2 weeks post-operation the patient was walking after physiotherapy, and had pain.X-rays revealed a fracture in the nail shaft.The nail was explanted and replaced with a titanium nail.

• Brand Name: PICCOLO COMPOSITE PROXIMAL FEMUR NAILING SYSTEM (NAIL)
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: yael rubin ; 11 ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 21891453
• Report Number: 9615128-2025-00002
• Device Sequence Number: 18167132
• Product Code: HSB
• UDI-Device Identifier: 07290109336459
• UDI-Public: (01)07290109336459(17)260201(10)X2179
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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 Expiration Date: 02/01/2026
• Device Catalogue Number: PPFL11420
• Device Lot Number: X2179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 82 KG