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

Catalog Number PDFLN2004

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the information and photos provided to the manufacturer, it seems that the breakage of the small fragment near the screw hole is a result of application of excessive torque upon screw tightening.This is not expected to adversely affect plate strength, as only a superficial layer was involved.As indicated in the system instructions for use, the user should avoid the application of high torque during screw tightening.It is noted that the plate remained in situ, with no additional activity required.Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.This report is submitted following an fda inspection at the manufacturer facility.Device is still implanted.

Event Description

A piccolo composite distal fibula plate was implanted in a patient in italy.When the surgeon tightened the most distal screw, a small fragment of the plate broke off from the surface of the device.The implant was remained in situ.

• Brand Name: A PICCOLO COMPOSITE DISTAL FIBULA 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: 6833777
• MDR Text Key: 84114246
• Report Number: 9615128-2017-00011
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07290109334275
• UDI-Public: (01)07290109334275(17)201001(10)90792
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2017

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: 10/01/2020
• Device Catalogue Number: PDFLN2004
• Device Lot Number: 90792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2015
• 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