MAUDE Adverse Event Report: PEGA MEDICAL INC THE FREE GLIDING SCFE SCREW SYSTEM; SCFE GUIDE WIRE COCR Ø2.0MM X 330MM

Model Number SCF-GWR320-CoCr

Device Problems Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

Part scf-gwr320-cocr are k-wires made of cobalt-chrome alloy as per (b)(4): standard specification for wrought cobalt-28chromium-6molybdenum alloys for surgical implants.Considering that this is an implantable material, the risk for the patient is deemed low.

Event Description

During a bilateral insertion of the sliding scfe screw, it was noted after removing the 2.0mm guide wire that the tip of the threaded portion was left in the patient during the second hip.It was not deemed to be in the way of the screw, and the surgeon has decided not to remove it.Both screws were inserted, and the outcome of the surgery was good and as planned.The tip of the wire is outside of the screw, as the distributor understood.The hospital has raised this as a foreign body left-in-patient incident.The wire that broke had been used in the first hip and was being used because the other wires (4 x supplied 2.0mm) were already bent during the surgery.So, it had already been used to insert the first screw.

• Brand Name: THE FREE GLIDING SCFE SCREW SYSTEM
• Type of Device: SCFE GUIDE WIRE COCR Ø2.0MM X 330MM
• Manufacturer (Section D): PEGA MEDICAL INC; 1111 autoroute chomedey; laval,, quebec H7W 5 J8; CA H7W 5J8
• Manufacturer (Section G): PEGA MEDICAL INC; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey; laval,, quebec H7W 5-J8 ; CA H7W 5J8
• MDR Report Key: 13548818
• MDR Text Key: 285852176
• Report Number: 3000327445-2022-00001
• Device Sequence Number: 1
• Product Code: HXI
• UDI-Device Identifier: 07540194008206
• UDI-Public: (01)07540194008206(10)13643-01
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCF-GWR320-CoCr
• Device Catalogue Number: SCF-GWR320-COCR
• Device Lot Number: 13643-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other