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

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problems Break (1069); Dull, Blunt (2407); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 12/26/2018

Event Type  Injury  

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 remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a rt.Total shoulder arthroplasty procedure a total of four drivers stripped.The first ar-9545-t15-03, driver stripped while tightening the 6.5 central non-locking screw.After the first driver stripped, an ar-9545-t15-02 (lot: 8001545) was used to finish implanting the 6.5 central non locking screw.It was used again for the superior peripheral 4.5 locking screw and screw stopped advancing and was stuck proud.The surgeon could not advance (several attempts) or extract it.Tip of the driver broke off in the screw when approx.1.5 mm proud.The head of the screw was burred down.Coring reamer could not seat, and the screw head was catching on it.Surgeon took the provisional glenosphere head and tried to mate it to the baseplate but concluded the glenosphere would be compromised if unable to achieve proper clearance.Surgeon was able to burr the head of the screw off for proper clearance.After tip of the second driver broke, an ar-9202-t15h was brought in.While using it to tighten the inferior peripheral 4.5 locking screw, the screw would not advance as it neared the baseplate.Surgeon extracted screw before it got stuck and went from a 36 length to a 30 length.Surgeon then noticed this driver was also stripped.After the third driver stripped an ar-9545-t15-01 was brought in to place the inferior peripheral 4.5 locking screw.This driver was also used to mate the suture cup implant to the stem implant.After all implants were seated the surgeon noted that all of the driver options used were stripped.The rep stated that they were present during the cleaning process and took pictures of the tips, and confirmed that they are all warped/stripped (see attached photo).During the same procedure the ar-9145k was discovered dull and switched out for a sharper one.The ar-9512, was also discovered stripped.After the issues with the drivers were resolved, the surgeon returned to the humerus and decided to switch from a tsa to a reverse tsa.The rep stated that they reminded the surgeon to start broaching with the reverse broaches as they have a different shape/length than the apex broaches.As the surgeon got to the 10 broach, the surgeon pulled the trigger on the broach handle which released the broach in the humerus.The surgeon could not retrieve it with the broach handle as it may have subsided slightly down the canal.Surgeon was given the broach extractor.The surgeon had difficulty mating it with the broach in the humeral canal, and could not thread it.Surgeon then tried to thread a broach on the back table so they could get an idea of the trajectory.This is when it was realized that it would not mate with any of the broaches because the threads were damaged on the extractor.Surgeon used a snap/hemostat to wiggle the broach back and forth and bring it proximal enough to get it to mate with the broach handle.Surgeon continued broaching and was able to reduce the shoulder and trial with the provisionals.Additional information received on 12/28/2018: ar-9145-30, lot 18.00832 was the screw that was burred off.The rep stated that just the 6.5 screw had the torque adapter on.After the issue with this screw, the torque adapter was not used.The baseplate impactor was used.All complaint devices will be returning.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: vik bajnath ; 8009337001
• MDR Report Key: 8252335
• MDR Text Key: 133202208
• Report Number: 1220246-2019-00856
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-30
• Device Lot Number: 18.00832
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other