MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS 6.5 X 25MM THREADED POST

Catalog Number DWJ125

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.For this event, trending analysis revealed this issue frequently occurred when surgeons attempted to seat the baseplate/screw construct, did not gain adequate fixation, then attempted to remove the screw from the baseplate to change the screw size.Testing has confirmed that once implanted the construct became "married" to the point that the screw cannot be removed.This issue has been escalated within our quality system and a note explaining this screw / baseplate event will be added to the surgical technique for the device system.

Event Description

It was reported that during surgery to implant a full wedge with a 6.5x25 center screw the screw did not get great bite.So an attempt was made to back the baseplate and screw out to switch to a 9.5.However, the attempt was unsuccessful in disassembling the 6.5 screw from the baseplate.Surgeon tried for 15 minutes and had to open up a new baseplate the issue resulted in extra surgery time and anesthesia to the patient.

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS 6.5 X 25MM THREADED POST
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: mary mcnabb ; 4375 e park 30 drive; columbia city, IN 46725 ; 5743713153
• MDR Report Key: 9643993
• MDR Text Key: 191303197
• Report Number: 3004983210-2020-00006
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DWJ125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention