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

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 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
• 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 9511511
• MDR Report Key: 6833780
• MDR Text Key: 84109905
• Report Number: 9615128-2017-00012
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07290109335230
• UDI-Public: (01)07290109335230(17)210201(10)90871
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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