MAUDE Adverse Event Report: PEGA MEDICAL INC. THE FREE-GLIDING SCFE SCREW SYSTEM; SCFE DRIVER THREAD Ø7.3MM - STD

Model Number SCF-SFT373

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The 7.3 screw was assembled onto the 7.3 green driver.The assembled screw was inserted into the reamed canal over 2.4 guidewire.After it was fully inserted, the surgeon disengaged the driver from the screw and took x-rays to confirm the position.Not satisfied with the position, the surgeon proceeded to re-engage the driver to the screw to back it up.After trying a few times, the driver threads would not re-engage the screw.Nonetheless, he was still able to use the driver to retract the screw to the desired position.After the driver was handed back to the scrub nurse, she began to disassemble it, and at this point, it was observed that the thread on the end of the internal shaft had broken off.The broken piece could not be found in the sterile field.Also, the broken fragment did not show on x-rays.

• Brand Name: THE FREE-GLIDING SCFE SCREW SYSTEM
• Type of Device: SCFE DRIVER THREAD Ø7.3MM - STD
• 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: 10895377
• MDR Text Key: 217980906
• Report Number: 3000327445-2020-00007
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07540194008008
• UDI-Public: (01)07540194008008
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCF-SFT373
• Device Catalogue Number: SCF-SFT373
• Device Lot Number: 160603-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Date Manufacturer Received: 10/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other