MAUDE Adverse Event Report: ARTHREX, INC. VA LOCKING SCREW, 1.4X9MM; PLATE, FIXATION, BONE

Model Number VA LOCKING SCREW, 1.4X9MM

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

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.

Event Description

It was reported the surgeon attempted to use screws and a plate but the screw head would not lock into the plate on either side.All was removed and retrieved and the case was completed with k-wire.

• Brand Name: VA LOCKING SCREW, 1.4X9MM
• 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: 10546217
• MDR Text Key: 207319759
• Report Number: 1220246-2020-02169
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867303713
• UDI-Public: 00888867303713
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VA LOCKING SCREW, 1.4X9MM
• Device Catalogue Number: AR-18714V-09
• Device Lot Number: 1063915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2019
• 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