MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI; PLATE, FIXATION, BONE

Model Number LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/06/2021

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 that during a fifth metacarpal fracture, when the surgeon was advancing the ar-18714-09, screw into the patient, once the screw was setting at 1mm before it was fully seated, the head broke.The screw remains in the patient but the head that broke was removed.The case was completed without further issue.

• Brand Name: LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI
• 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: 11872257
• MDR Text Key: 255339849
• Report Number: 1220246-2021-03145
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867303867
• UDI-Public: 00888867303867
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI
• Device Catalogue Number: AR-18714-09
• Device Lot Number: 2684402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Date Device Manufactured: 10/28/2019
• 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