MAUDE Adverse Event Report: ARTHREX, INC. Y-PLATE, 1.6MM, 6 HOLE; PLATE, FIXATION, BONE

Model Number Y-PLATE, 1.6MM, 6 HOLE

Device Problems Break (1069); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2021

Event Type  malfunction  

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

It was reported during a procedure the ar-18716p-10 plate was damaged during the attempted cut and the tip of the ar-18700-09 driver broke off into the screw head.Additional information provided 6/8/21: the broken tip of ar-18700-09 was unable to be removed from the screw head.The driver tip broke completely flush within the screw head and the surgeon was unable to remove it.The case was completed by removing the entire screw from the patient using a needle nose pliers, and using a less optimal plate because the most optimal plate we needed was bent during an attempted cut.Both devices were discarded.

• Brand Name: Y-PLATE, 1.6MM, 6 HOLE
• Type of Device: PLATE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 11991255
• MDR Text Key: 259471850
• Report Number: 1220246-2021-03275
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867313422
• UDI-Public: 00888867313422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Y-PLATE, 1.6MM, 6 HOLE
• Device Catalogue Number: AR-18716P-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1