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

Model Number	SCF-SFT373
Medical Device Problem Codes	Fracture (1260); Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SCFE DRIVER THREAD Ø7.3MM - STD
• Manufacturer (Section D): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• MDR Report Key: 10895377
• Report Number: 3000327445-2020-00007
• Device Sequence Number: 19540327
• Product Code: HXX
• UDI-Device Identifier: 07540194008008
• UDI-Public: (01)07540194008008
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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-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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other