MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PROXIMAL FEMORAL NAIL; PF NAIL

Model Number	Proximal Femur Nail
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on x-rays provided to the company, the case involved a bone loss (with a large fracture gap).Examination of the involved nail indicated it had a fatigue fracture at the area of the bone loss.Examination of production records of the involved device indicated the implant was manufactured according to specification.It is noted that as indicated in the literature the risk of implant fatigue failure in the case of pathological femoral fractures is high.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 piccolo composite pf nail was implanted to treat a pathologic fracture.About 3 weeks after implantation, the nail broke and was replaced.Based on the x-rays provided to the company, the case involved significant bone loss with large fracture gap.

• Brand Name: PICCOLO COMPOSITE PROXIMAL FEMORAL NAIL
• Common Device Name: PF NAIL
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; 4672411; herzeliya, ; IS
• MDR Report Key: 7702063
• Report Number: 9615128-2018-00006
• Device Sequence Number: 13683169
• Product Code: HSB
• UDI-Device Identifier: 07290109336480
• UDI-Public: (01)07290109336480(17)211101(10)PPF00989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: 11/01/2021
• Device Model Number: Proximal Femur Nail
• Device Catalogue Number: PPFR11320
• Device Lot Number: PPF00989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/19/2018
• 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: 56 YR