MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 14MM; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.5MMX 14MM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-8935-14 low profile screw head broke off the body of the screw while inserting it.This was discovered during an orif lt ankle procedure on (b)(6) 2022.Additional information received on 10/19/2022: the body of the screw remains implanted in the patient and case was completed successfully without further issues.
Additional 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.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 14MM
• Common Device Name: 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: 15743573
• Report Number: 1220246-2022-05714
• Device Sequence Number: 20249182
• Product Code: HWC
• UDI-Device Identifier: 00888867050402
• UDI-Public: 00888867050402
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 14MM
• Device Catalogue Number: AR-8935-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown