MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 60MMCORT; SCREW, FIXATION, BONE

Model Number LO-PRO SCRW TM,SS 3.5X 60MMCORT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

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

On 1/17/2023, it was reported by a facility representative via medwatch email that an ar-8835-60 low profile screw head broke during the procedure on (b)(6) 2022.The body of the screw remains in the patient and broken head was retrieved.No further information has been provided at this time.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 60MMCORT
• Type of Device: SCREW, 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: 16303294
• MDR Text Key: 308891263
• Report Number: 1220246-2023-06237
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203239
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW TM,SS 3.5X 60MMCORT
• Device Catalogue Number: AR-8835-60
• Device Lot Number: 1229434
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2023
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1