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	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A cancer patient with an oncological lesion in the femoral area underwent pf nail implantation surgery in (b)(6) for impending fracture.The weight of the patient was 95 kg, height 1.57 meters.About two months post-operatively, the patient was delivered to the emergency room.X-ray taken revealed an atraumatic peri-implant fracture above the nail, and did not indicate that the nail was broken.After three days a revision surgery was conducted, during which it was shown that the nail was broken at the mid-shaft area.The fractured nail was extracted and replaced.
Additional Manufacturer Narrative
The involved nail was received and underwent an examination by the company.Examination of the nail, including microscopic visual inspection, indicated it had a fatigue fracture, probably aggravated by the patient's condition:an oncological lesion and overweight.Dimensional examination, to the extent possible, did not reveal deviation from specification.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 (b)(4).The risk of implant failure increases in case of pathological fractures, as in the described case.(1).(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.Note: originally, this report was submitted on july 13, 2022.Recently it was noted that the e-submission has failed (as indicated in the fda ack3).The error listed in ack3 has been corrected and the emdr is resubmitted.

• 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
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: alexandra vikanova ; 11 ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 15223663
• Report Number: 9615128-2022-00004
• Device Sequence Number: 5978052
• Product Code: HSB
• UDI-Device Identifier: 07290109336404
• UDI-Public: (01)07290109336404(17)230701(10)PPF01418
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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: 07/01/2023
• Device Model Number: Proximal Femur Nail
• Device Catalogue Number: PPFL11320
• Device Lot Number: PPF01418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 95 KG