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

Catalog Number PDFLN2006

Device Problems Material Fragmentation (1261); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the manufacturer's investigation, the lack of part of the tantalum marker was a result of a human error.The company has already implemented means to verify during production process the integrity of the marker along the plate.The minor damage near the screw hole was probably caused by excessive torque applied upon screw tightening.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, and that the incident is not expected to adversely affect plate strength, as only a superficial layer was involved.

Event Description

The tantalum wire marker did not run the entire length of the plate.In addition, when the locking screw was tightened, a superficial small fragment raised near the hole.The procedure was completed without delay or issue.

• Brand Name: 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
• MDR Report Key: 7338254
• MDR Text Key: 102446193
• Report Number: 9615128-2018-00002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

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: 06/01/2022
• Device Catalogue Number: PDFLN2006
• Device Lot Number: 91425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• 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: 74 YR