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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a complex hwr of spanning plate and orif distal radius, possible arthrex plate, possible wrist ex-fix, orif druj, triceps revision/repair procedure, the plate was removed and reduction of the fracture was performed.When manipulating the fracture, the surgeon mentioned that the bone was subpar and x-rays showed the same.He asked to use the arthrex drp set; it was opened and he chose to use the standard left 3-hole plate, ar-8916vsl-03.He inserted a 3.5 cortical screws in the oblong hole and didn't like the fit, so he took it out and bent the plate.Inserted a 3.5 screw back into the oblong hole and liked the fit much better.He asked for the locking tower, then about variable angle, so we gave him the val guide and rep told him he had a 20 degree cone.He drilled, measured and inserted a 20mm 2.4 val, ar-8724v-20, screw in the central-medial hole.Rep didn't have direct visualization but saw him back the screw out, or try to, and then asked why our driver tips are blunt.The rep gave him the other tip from the set and he stripped the screw.He pulled the the 3.5 screw out, pulled the plate out and said the 2.4 went through the plate.He then asked for a set by a different manufacturer and started putting there drp plate on.Rep obtained the plate and screw from the scrub and stayed for the rest of the distal radius orif running the c-arm.Additional information provided 8/9/2021: date of first surgery was approximately one month prior to the revision the surgeon was doing on (b)(6) 2021.A revision was being performed because the was a nonunion of the distal radius.The first surgery was not done with any arthrex products and was not done by dr.Viola.The pn of the driver is not known.
Additional Manufacturer Narrative
The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to user error due to over-torguing of the driver during insertion of the 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: emily shafer ; 8009337001
• MDR Report Key: 18684574
• Report Number: 1220246-2023-09218
• Device Sequence Number: 17737404
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/12/2024

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: 11501353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• 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