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

Model Number	Proximal Femur Nail
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The involved item was received and underwent an examination by the company.Examination of the nail, including microscopic visual inspection, indicated it had a fatigue fracture.Examination of the production records of the involved device indicated the implant was manufactured according to specification.Breakage of proximal femur nails is known and documented in the literature, with reported rates that range from 0.2% to 5.6%(1).The risk of implant fatigue failure increases in the case of pathological fractures, like in the reported case.The reported case involved a (b)(6) year old patient with a tumor.Importantly, nail withheld for more than 9 months which is considered a long period in cases with compromised bone healing.(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
A proximal femur nail was implanted to treat a pathologic fracture (oncological patient) in (b)(6).More than 9 months post-operation, nail broke at the sub-trochanteric area and was replaced with a metal nail in a revision surgery.

• Brand Name: PICCOLO COMPOSITE PROXIMAL FEMUR NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD SYSTEM
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 10028610
• Report Number: 9615128-2020-00005
• Device Sequence Number: 777035
• Product Code: HSB
• UDI-Device Identifier: 07290109336534
• UDI-Public: (01)07290109336534(17)220901(10)PPF01196
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K153536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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: 09/01/2022
• Device Model Number: Proximal Femur Nail
• Device Catalogue Number: PPFR11420
• Device Lot Number: PPF01196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR