MAUDE Adverse Event Report: ARTHREX, INC. H-PLATE, 32 X 16MM, 6MM WEDGE, RIGHT; BONE FIXATION PLATE

Model Number H-PLATE, 32 X 16MM, 6MM WEDGE, RIGHT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 12/12/2023, it was reported by a distributor via sems-06428823 that an ar-8942r-06 low profile h-plate, ti, 6 mm wedge, right was removed during a revision distal tibia opening wedge procedure on (b)(6) 2023.The primary repair failed; the screws broke.During the revision surgery, the surgeon noticed that the plate had melted debris on top.The plate was removed carefully because the melted debris itself was attached to the patient's soft tissue.No further information was provided.Additional information requested.

• Brand Name: H-PLATE, 32 X 16MM, 6MM WEDGE, RIGHT
• Type of Device: 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: 18487823
• MDR Text Key: 332603211
• Report Number: 1220246-2024-00255
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867051997
• UDI-Public: 00888867051997
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-PLATE, 32 X 16MM, 6MM WEDGE, RIGHT
• Device Catalogue Number: AR-8942R-06
• Device Lot Number: 01091711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other