MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 18MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO LOCK SCRW,SS 2.7X 18MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2021
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.Discarded by facility.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or over-torquing the driver within the screw head.
Event or Problem Description
On 09/23/2021, it was reported by a sales representative via phone that (3) ar-8827l-18 low profile locking screw would not engage into the plate.This was discovered during use in a clavicle fracture on (b)(6) 2021.The case was completed by placing only 2 out of the 5 screws into the plate, leaving 3 of the holes empty.

• Brand Name: LO-PRO LOCK SCRW,SS 2.7X 18MM
• 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: 19276962
• Report Number: 1220246-2024-02996
• Device Sequence Number: 7649416
• Product Code: HWC
• UDI-Device Identifier: 00888867047075
• UDI-Public: 00888867047075
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 18MM
• Device Catalogue Number: AR-8827L-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown