MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD LT 3H; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI STD LT 3H
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
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.Complaint confirmed, even though the screw was not returned, one of the 7 threaded holes on the plate head was found to have damaged threads resulting in an oversized minor diameter, however a likely cause is over-torqueing the locking screw.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tightening the screw.
Event or Problem Description
It was reported that during a distal radius fracture repair procedure, as the surgeon was inserting the ar-8724-22 2.4mm screw into the ar-8916vsl-03, volar distal radius plate, as the surgeon was completing the final tightening, the screw head went straight through.The surgeon removed the plate and screw.The case was completed using a different ar-8916vsl-03, lot: 0290944 and ar-8724v-20, 2.4mm locking screw.

• Brand Name: VOLAR DISTAL RAD PLT TI STD LT 3H
• Common Device Name: BONE FIXATION 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: 19547045
• Report Number: 1220246-2024-05862
• Device Sequence Number: 20046389
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: VOLAR DISTAL RAD PLT TI STD LT 3H
• Device Catalogue Number: AR-8916VSL-03
• Device Lot Number: 10282300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown