MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL HUMERAL PLATE, 8 HOLE; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	PROXIMAL HUMERAL PLATE, 8 HOLE
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 10/27/2023, it was reported by a sales representative via email that a 3012-008 proximal humeral plate distal locking holes seemed to be crossed-threaded and did not accept multiple 8114-028 cortical screws.When the screws were implanted, they would spin in place and went right through the plate.This was discovered during a proximal humeral fracture procedure on 10/24/2023.Additional information received on 10/30/2023: the case was completed using a 3012-011 proximal humeral plate with multiple 8114-028 cortical screws.
Additional Manufacturer Narrative
The complaint is confirmed.One unpacked 3012-008 proximal humeral plate, 8-hole, batch 180576, was received for evaluation.Visual inspection found nicks, bends, and damage on the threads of the screw holes.It was noted that one threaded hole lost its geometry because of a missing piece.The most likely cause for the reported failure is a user error.It is possible that the incorrect screw size was used or the screw insertion angle was wrong.When two devices are intended to be threaded together, ensure they are fully engaged before use.

• Brand Name: PROXIMAL HUMERAL PLATE, 8 HOLE
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: emily shafer ; 8009337001
• MDR Report Key: 18192114
• Report Number: 1220246-2023-08879
• Device Sequence Number: 7237991
• Product Code: HRS
• UDI-Device Identifier: 00848665006360
• UDI-Public: 00848665006360
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PROXIMAL HUMERAL PLATE, 8 HOLE
• Device Catalogue Number: 3012-008
• Device Lot Number: 180576
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown