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

Model Number Distal Femur Plate

Device Problems Failure To Adhere Or Bond (1031); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2016

Event Type  malfunction  

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 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
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: hila wachsler-avrahami ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411 ; 9 951511
• MDR Report Key: 6833779
• MDR Text Key: 84109314
• Report Number: 9615128-2017-00013
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07290109335230
• UDI-Public: (01)07290109335230(17)210101(10)90848
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR