MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
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 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 during a left shoulder rtsa procedure, the surgeon was inserting the inferior screw of the universal baseplate.Initially, the bit had the torque driver on it; he inserted it with about 5mm left and took off the torque wrench.He proceeded to insert the screw and with about 2mm left before it was seated, the tip of the bit broke off in the head of the screw.The bit was unusable and the screw was still proud.The surgeon then attempted to use a dental pic and a screw removal set to dislodge the piece of the bit that was still retained in the head of the screw which did not work.He eventually used a metal cutting burr which also did not work.After talking through options he decided to use the same burr and cut off the top of the screw.He trialed a glenosphere and found no issue with the implant seating properly so the case finished with no further issues.Additional information provided 02/19/2020: the surgeon was aware that taking the torque driver off was not the best idea.It was on the bit when he first started inserting the locking screws.Patient is a male, (b)(6).

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9808430
• Report Number: 1220246-2020-01756
• Device Sequence Number: 16894633
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: 00888867057739
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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 Expiration Date: 03/31/2024
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Device Lot Number: 18.01605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/09/2020
• 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
• Patient Age: 73 YR