MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 20MM VAL SCREW, TI; PLATE, FIXATION, BONE

Model Number	2.4 X 20MM VAL SCREW, TI
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	08/08/2018
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 device disposition was unknown by the reporter.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
During social safeguard cyber review (arthrex chatter community) a potential device issue was discovered.Upon further investigation it was confirmed on (b)(6) 2018 that a revision procedure had taken place.Additional information was requested.Additional information obtained 9/5/18: a patient had a distal radius fracture procedure on (b)(6) 2018.During the procedure the following devices were implanted: ar-8916vnl-03, lot 10183688 (qty 1), ar-8724v-20 (qty 4 lot unknown), ar-8935l12 (qty 1 lot unknown), ar-8935l-14 (qty 1 lot unknown), and ar-8935-12 (qty1 lot unknown).The patient suffered a fall and had a revision procedure on (b)(6) 2018.During the revision procedure all of the original implants were removed and replaced.The following devices were implanted to complete the procedure: ar-8916vnl-03 lot 10189728 (qty1), ar-8724v-18 (qty1 lot unknown), ar-8724v-22 (qty 3 lot unknown), ar-8935l-12 (qty1 lot unknown), ar-8935l-14 (qty 1 lot unknown), and ar-8935-12 (qty1 lot unknown).Per reporter it is unknown when the patients pain began or if patient had any other symptoms prior to the patient's fall.No cultures were taken or any other problems found during revision surgery.The explanted devices are not available to return as the device disposition is unknown by the reporter.

• Brand Name: 2.4 X 20MM VAL SCREW, TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7890094
• Report Number: 1220246-2018-00653
• Device Sequence Number: 1862259
• Product Code: HRS
• UDI-Device Identifier: 00888867045620
• UDI-Public: 00888867045620
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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 Model Number: 2.4 X 20MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/19/2018
• 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