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
Medical Device Problem Codes	Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3000327445-2022-00001
• Device Sequence Number: 3696301
• Product Code: HXI
• UDI-Device Identifier: 07540194008206
• UDI-Public: (01)07540194008206(10)13643-01
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown