MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,50MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,4.0 STD,50MM LGTH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/19/2021, it was reported by an arthrex employee via email that an ar-8740-50h screw broke during insertion of the medial malleolus.This occurred during a arthroscopic medial malleolus orif on (b)(6) 2021 proper preparation of the bone socket was done as observed, the first half was inserted with power subsequently then switched to hand, the screw broke after a few turns by hand.The broken point was at the conjunction of the cortical and cancellous thread.The screw was removed using pliers, and the incision was extended in order to access the broken part of the screw.A downsized screw was used after to complete the case.The surgery was delayed to this incident.Additional information requested.Additional information provided on 10/20/2021 there¿s no lot number on the screw as it wasn¿t a single packed product.Thus i couldn¿t provide the lot number.A 1.1mm guidewire and 3.2mm cannulated drill bit was used to prepare bone socket.Bone should be hard as patient is young.Operation was delayed for about 30mins.Additional anaesthetic was required.A 4x40mm screw was used to complete the operation after the broken screw been removed.
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.
Additional Manufacturer Narrative
This follow-up for 1220246-2021-03884 is to update and change section b1 to adverse event from the initial submission of product problem.Also, section h1, the type of reportable event is now "serious injury" change from "malfunction" in the original submission of 1220246-2021-03884.

• Brand Name: COMPR FT SCRW,4.0 STD,50MM LGTH
• Common Device Name: PLATE, 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: 12770320
• Report Number: 1220246-2021-03884
• Device Sequence Number: 4638620
• Product Code: HRS
• UDI-Device Identifier: 00888867127937
• UDI-Public: 00888867127937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: COMPR FT SCRW,4.0 STD,50MM LGTH
• Device Catalogue Number: AR-8740-50H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown