MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI; BONE FIXATION PLATE

Model Number LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2023

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 (b)(6) 2023, it was reported by a sales representative via email that an ar-18714-11 low profile screw, an ar-18714-12 low profile screw, and an ar-18714v-11 va locking screw broke during insertion into the plate.This was discovered during a metacarpal fx procedure on (b)(6) 2023.The screws remain inside the patient.Additional information requested.

• Brand Name: LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17099931
• MDR Text Key: 316898557
• Report Number: 1220246-2023-06888
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867303843
• UDI-Public: 00888867303843
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI
• Device Catalogue Number: AR-18714-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2023
• 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