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 Codes	Hip Fracture (2349); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The case involved an osteopetrosis patient with nonunion and implant failure after three months.Examination of involved nail manufacturing records indicated the implant was manufactured according to specification.The implant was not available to the company; thus, its physical examination was not possible.X-rays provided (of post nail failure) indicated the case involved nonunion of the fracture.Cases of nonunion as well as subsequent implant failure are known and documented in the literature, with reported nail breakage rates that range from 0.2% to 5.6% (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.
Event or Problem Description
A proximal femur nail was implanted to treat a sub-trochanteric fracture in a patient with osteopetrosis.Approximately 3 months after implantation, nail broke and was removed 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: 10383119
• Report Number: 9615128-2020-00009
• Device Sequence Number: 19137296
• Product Code: HSB
• UDI-Device Identifier: 07290109336510
• UDI-Public: (01)07290109336510(17)240501(10)PPF01580
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2020

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: 05/01/2024
• Device Model Number: Proximal Femur Nail
• Device Catalogue Number: PPFR11380
• Device Lot Number: PPF01580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/09/2020
• 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