MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 14MM; SCREW, FIXATION, BONE

Model Number	LOCKING SCREW, TITANIUM 3.5MM X 14MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is an initial report to resubmit all prior information that was submitted through arthrex submission the initial reports dropped from the fda system and therefore blocked the full processing of a follow up submission.The 2 submissions went through but only the receipt and 1 acknowledgement with no core id were received.After several months of investigation with the fda, due to computer system changes at arthrex as well as the fda, the fda has agreed that arthrex should resubmit a new report to encompass the initial prior 2017 arthrex submissions involved.This report is in reference to: 1220246-2017-00332 (arthrex reference#: (b)(4) / line 204830.Complaint confirmed.The evaluation revealed that the returned two screws have minor damages.The damages were most likely caused during the extraction of the screws.Measurements taken on screw revealed that their critical dimensions were within specification.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.
Event or Problem Description
This is an initial report to resubmit all prior information that was submitted through arthrex submission the initial reports dropped from the fda system and therefore blocked the full processing of a follow up submission.The 2 submissions went through but only the receipt and 1 acknowledgement with no core id were received.After several months of investigation with the fda, due to computer system changes at arthrex as well as the fda, the fda has agreed that arthrex should resubmit a new report to encompass the initial prior 2017 arthrex submissions involved.This report is in reference to: 1220246-2017-00332 (arthrex reference: (b)(4)/ line 204830).The following is the previously reported information mentioned above: it was originally reported that the screws began to change angle after being implanted.Additional information received on 8/24/2017: it was reported that the patient underwent distal radius repair on (b)(6) 2017.On (b)(6) 2017, the patient was experiencing pain and displacement.The volar distal radius plate along with all the screws were removed on (b)(6) 2017.Additional information received 8/31/2017: the issue was found during routine follow up with x-rays.No arthrex devices were implanted during revision surgery.

• Brand Name: LOCKING SCREW, TITANIUM 3.5MM X 14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10774432
• Report Number: 1220246-2020-02298
• Device Sequence Number: 14363819
• Product Code: HWC
• UDI-Device Identifier: 00888867050853
• UDI-Public: 00888867050853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: LOCKING SCREW, TITANIUM 3.5MM X 14MM
• Device Catalogue Number: AR-8935L-14
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other