MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM; BONE FIXATION PLATE

Model Number	DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2022
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.One unpackaged ar-8771-0422x dynanite comp plate, 4-hole square, 22mm, serial batch number (b)(6), was received for investigation, and no screws were returned.Visual evaluation observed some metal shaving on the dynanite comp plate holes (on two holes).Also, it was observed a missing piece of the dynanite comp.Plate.Edge.No other visual issues were observed on the thread of the plate.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the screws during use.Refer to investigation photos #1-5 for further details.
Event or Problem Description
On 7/13/2022, it was reported by a sales representative via email that an ar-8771-0422x dynanite compression plate was implanted without any issues.After the plate was secure with four 3.0mm hybrid locking screw, a t10 screw driver was used to remove the compression device.However, the screw immediately stripped and had metal shaving come out, impeding the driver from engaging again.Surgeon attempted to use pliers to turn the screw counter clockwise and engage the compression device, but the screw would not budged.This was discovered during a talar-navicula arthrodesis procedure on (b)(6) 2022.Additional information received on 7/14/2022: surgeon had to remove the entire compression plate along with the screws and use a new ar-8771-0422x dynanite compression plate, from lot 13434733, along with the same screws from the previous plate, to complete the case.

• Brand Name: DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM
• 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: 19280102
• Report Number: 1220246-2024-03047
• Device Sequence Number: 6338719
• Product Code: HRS
• UDI-Device Identifier: 00888867339897
• UDI-Public: 00888867339897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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 Expiration Date: 05/31/2026
• Device Model Number: DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM
• Device Catalogue Number: AR-8771-0422X
• Device Lot Number: 13434733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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