MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW; INTRAMEDULLARY FIXATION ROD SYSTEM

Model Number Lag Screw

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided to the company, tapping was not performed prior to lag screw insertion into the bone.It was indicated that the case involved a hard bone.As listed in the system ifu and surgical technique, tapping should be performed before lag screw threading into the bone, using the provided bone tap.It is noted that the operation was satisfactorily completed, and that having double titanium shell is not expected to adversely affect the device performance or the clinical outcome.Based on recent information from the surgeon, the patient is feeling well.Examination of the involved lag screw indicated that the entire titanium shell was removed from the threaded portion at lag screw' distal end.No production fault was detected on visual and dimensional examination of the lag screw.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.

Event Description

During implantation of a piccolo composite pf nail and screws, the surgeon decided to replace the lag screw which was just introduced with a longer one.Upon removing the lag screw from the bone, the screw' titanium shell remained in the bone.Another lag screw was used, threaded into the remaining titanium shell.The operation was satisfactorily completed.

• Brand Name: PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW
• Type of Device: INTRAMEDULLARY FIXATION ROD SYSTEM
• 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: 6833850
• MDR Text Key: 84109598
• Report Number: 9615128-2017-00019
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07290109335452
• UDI-Public: (01)07290109335452(17)210701(10)PPF00580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153536
• 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: 04/04/2017

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: 07/01/2021
• Device Model Number: Lag Screw
• Device Catalogue Number: PPFLS10080
• Device Lot Number: PPF00580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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: 46 YR