MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 3.5X 12MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO LOCK SCRW,SS 3.5X 12MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2021
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 most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On 09/20/2021, it was reported by a sales representative via (b)(4) that an ar-8835l-12 lo-pro locking screw (line #1) and ar-8835l-16 lo pro locking screw (line #2), would not lock into the plate.This was discovered during use in a clavicle fracture on (b)(6) 2021. the case was completed by swapping out the screws.

• Brand Name: LO-PRO LOCK SCRW,SS 3.5X 12MM
• 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: 19468353
• Report Number: 1220246-2024-04926
• Device Sequence Number: 3455995
• Product Code: HWC
• UDI-Device Identifier: 00888867047532
• UDI-Public: 00888867047532
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/05/2024

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 3.5X 12MM
• Device Catalogue Number: AR-8835L-12
• Device Lot Number: 10285940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2019
• 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