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

Catalog Number	AR-8935-20
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is one of three submissions from the same case.The others are (b)(4).Lot number was not provided so device history record review cannot be performed.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was originally reported that the screws began to change angle after being implanted.Follow-up investigation: 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.The issue was found during routine follow up with x-rays.No arthrex devices were implanted during revision surgery.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission due to device evaluation.Lot number was not provided so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the returned screw has minor damages.The damages were most likely caused during the extraction of screw.Measurements taken on screw revealed that its 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
It was originally reported that the screws began to change angle after being implanted.Follow-up investigation: 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.The issue was found during routine follow up with x-rays.No arthrex devices were implanted during revision surgery.

• Brand Name: LO-PROFILE SCREW,TI,3.5MMX 20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6864202
• Report Number: 1220246-2017-00333
• Device Sequence Number: 18863337
• Product Code: HRS
• UDI-Device Identifier: 00888867050464
• UDI-Public: 00888867050464
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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 Catalogue Number: AR-8935-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 02/22/2018
• 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