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
Examination of the involved plate revealed that the recess intended for handle connection was located with a 0.1 mm offset; this results in a difficult (although possible) plate-handle connection.Following investigation of the case, 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.
Event or Problem Description
During operation, it was difficult to connect a piccolo composite distal femur plate and its handle (outside the patient body).Another plate was used.

• 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: 6833780
• Report Number: 9615128-2017-00012
• Device Sequence Number: 1430649
• Product Code: HRS
• UDI-Device Identifier: 07290109335230
• UDI-Public: (01)07290109335230(17)210201(10)90871
• 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
• 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: 02/01/2021
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFELN1810
• Device Lot Number: 90871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2017
• 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