MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 28MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 28MMCORT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/11/2023, it was reported by an arthrex employee via email that an ar-8835-28 low profile screw was faulty.This was discovered upon opening the package during a procedure on (b)(6) 2023.
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 returned low-profile screw was visually inspected, and it was noted that the hexalobe head geometry and the thread pitch were damaged.Nicks, bent, and scratches were observed throughout the thread length and inside the hexalobe head.It was observed tool marks on the screw tip.Based on the device damage that was reported, the most likely cause for the reported failure can be attributed to misuse/mishandling.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 28MMCORT
• 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: 19491428
• Report Number: 1220246-2024-05251
• Device Sequence Number: 7107277
• Product Code: HWC
• UDI-Device Identifier: 00888867047358
• UDI-Public: 00888867047358
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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 SCRW TM,SS 3.5X 28MMCORT
• Device Catalogue Number: AR-8835-28
• Device Lot Number: 14949292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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