MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 10MM, CORTEX; SCREW, FIXATION, BONE

Model Number	LOW PROFILE SCREW, 2.4 X 10MM, CORTEX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
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 was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the surgeon had to remove the wrist spanning plate, ar-8916spn, because the screws were backing out of the distal holes.No further information, additional information requested.Additional information provided 12/18/19: case date of implantation: (b)(6) 2019, case date of explantation: (b)(6) 2019.The following screws were also explanted during the revision: ar-8916spn lot: 105641930, ar-8724-10 lot: w646301, ar-8724v-10 lot: 2610171, ar-8724v-12 lot: w657601, ar-8935-14 lot: 10279504, ar-8935l-12 lot: 10257929, ar-8935l-14 lot: 10277889.

• Brand Name: LOW PROFILE SCREW, 2.4 X 10MM, CORTEX
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9557183
• Report Number: 1220246-2020-01546
• Device Sequence Number: 2340918
• Product Code: HWC
• UDI-Device Identifier: 00888867045071
• UDI-Public: 00888867045071
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: LOW PROFILE SCREW, 2.4 X 10MM, CORTEX
• Device Catalogue Number: AR-8724-10
• Device Lot Number: W646301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/07/2020
• 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