MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE DISTAL FEMUR PLATE; BONE PLATE

Model Number	Distal Femur Plate
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the manufacturer investigation, the difficult plate-handle connection was the result of minor offset in the location of plate recess intended to connect the plate to the insertion handle.It is noted, that although difficult, connection was possible; the plate was satisfactorily implanted.It was concluded that the reported case was a result of a manufacturing fault.This report is submitted following an fda inspection at the manufacturer facility.Device is still implanted.
Event or Problem Description
During operation, it was difficult to connect a piccolo composite distal femur plate and its handle (outside the patient body).Nevertheless, the physician succeeded to connect the insertion handle to the plate, and the plate was satisfactorily implanted.It was noted that the tantalum wire did not extend through the entire plate perimeter.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 6833779
• Report Number: 9615128-2017-00013
• Device Sequence Number: 1589449
• Product Code: HRS
• UDI-Device Identifier: 07290109335230
• UDI-Public: (01)07290109335230(17)210101(10)90848
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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: 01/01/2021
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFELN1810
• Device Lot Number: 90848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR