MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 20MM; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.5MMX 20MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-8935-20 low profile screw head broke while attempting to do the final turn after inserting it into an ar-9943t-06 locking third tubular plate.The head of the screw was retrieved; however, the body was able to hold the reduction of the fraction and was left in the patient.No additional screws needed to be used.This was discovered during an ankle fracture procedure on (b)(6) 2021.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 20MM
• 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: 15870789
• Report Number: 1220246-2022-05815
• Device Sequence Number: 20508202
• Product Code: HWC
• UDI-Device Identifier: 00888867050464
• UDI-Public: 00888867050464
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/28/2022

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 20MM
• Device Catalogue Number: AR-8935-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown