MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. FIXION IL HUMERAL NAIL; INTRAMEDULLARY FIXATION ROD SYSTEM

Model Number	Interlocking Humeral Nail
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.Based on investigation findings, it seems that the nail' distal tip may have hit the cortex at the entry point or at the fracture site and thus was distorted.This report is submitted following an fda inspection at the manufacturer facility.Note: this product is no longer marketed in the usa.
Event or Problem Description
During implantation of a fixion il humeral nail in (b)(6), the nail was bent near its distal end.

• Brand Name: FIXION IL HUMERAL NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD SYSTEM
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 6857293
• Report Number: 9615128-2017-00034
• Device Sequence Number: 1141400
• Product Code: HSB
• UDI-Device Identifier: 07290109330815
• UDI-Public: (01)07290109330815(17)201201(10)IHN00429
• Combination Product (Y/N): N
• PMA/510(K) Number: K013449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: Interlocking Humeral Nail
• Device Catalogue Number: 2111026
• Device Lot Number: IHN00429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2016
• Initial Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1