MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 42MM; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.5MMX 42MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
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) 2023, it was reported by a sales representative via email that an ar-8935-42 low profile screw broke during insertion, on the final tightening.Surgeon predrilled with a 2.5mm drill using a soft tissue guide and placed the screw first under power and then by hand when the head of the screw broke off from the shaft of the screw.The head was retrieved from inside the patient.This was discovered during an ankle fracture procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional info: b1, b2, b5: complaint confirmed.Upon visual evaluation, it was noted that the head had broken off of the body of the device.The outer diameter of the head was measured and found to meet device specifications.The inner diameter of the hexalobe was also measured and found to meet the drawing specifications.The material of the device was tested as well and found to meet the specific composition required by the drawing.The cause of these remains undetermined.
Event or Problem Description
Additional information is received on 2/21/2023: the case was completed after adding three more screws to the plate.The broken body of the screw was left in place.The body of the screw had no head, therefore, there was no way to remove the screw.This was discovered during an orif of a non-union medial malleolus fracture.A 6-hole 1/3 tubular plate was used from the same titanium ankle fracture set- the plate was not changed.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 42MM
• 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: 16528642
• Report Number: 1220246-2023-06412
• Device Sequence Number: 5410941
• Product Code: HWC
• UDI-Device Identifier: 00888867050686
• UDI-Public: 00888867050686
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.5MMX 42MM
• Device Catalogue Number: AR-8935-42
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown