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

Catalog Number	PPFR11420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/16/2024
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 (nor the case x-rays) was not available to the manufacturer; therefore, nail physical examination was not feasible.Although the nail could not be examined, the fact that it fractured after five months in metastatic bone with non-union suggests a fatigue fracture.Breakage of proximal femur nails is known and documented in the literature, with reported rates that range from 0.2% to 5.6%.The risk of implant failure increases in case of pathological fractures, as in the described case.[1] the company is actively seeking for more data.[1] johnson na et al., risk factors for intramedullary nail breakage in proximal femoral fractures: a 10-year retrospective review.Ann r coll surg engl.2017; 99(2): 145-150.
Event or Problem Description
On march 16, 2026, the company became aware of a case involving its piccolo composite pf nail.Based on the information provided to the company, the device was implanted in an oncologic patient with femoral metastases on (b)(6) 2024, following a fall resulting in a pathological fracture of the femur.Approximately five months post-implantation, the nail fractured at or near the lag screw interface due to non-union.On (b)(6) 2025, the nail was removed and replaced with a total hip prosthesis.

• 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: hila wachsler avrahami ; 11 ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 24686360
• Report Number: 9615128-2026-00001
• Device Sequence Number: 15884433
• Product Code: HSB
• UDI-Device Identifier: 07290109336534
• UDI-Public: (01)07290109336534(17)271001(10)X2647
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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 Catalogue Number: PPFR11420
• Device Lot Number: X2647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American