MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 10MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO LOCK SCRW,SS 2.7X 10MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause of the reported failure is use error.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
It was reported that during a procedure, the surgeon/scrub tech did not realize they were using a cannulated driver and cross threaded the locking screw into the plate.The torque on the driver broke the driver and the screw and they were unable to get the screw out of the plate.Additional information 4/9/2021 it was reported that during an ankle fracture repair procedure, the surgeon/scrub tech did not realize they were using a cannulated driver and cross threaded the locking screw into the plate.The implant screw was cross threaded into the plate and the whole thing pulled out of the patient¿s bone.The torque on the driver broke the driver and the screw and they were unable to get the screw out of the plate.The case was completed using a new plate, screw and driver.

• Brand Name: LO-PRO LOCK SCRW,SS 2.7X 10MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19376170
• Report Number: 1220246-2024-03678
• Device Sequence Number: 15375759
• Product Code: HWC
• UDI-Device Identifier: 00888867047037
• UDI-Public: 00888867047037
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: LO-PRO LOCK SCRW,SS 2.7X 10MM
• Device Catalogue Number: AR-8827L-10
• Device Lot Number: 10267602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown