MAUDE Adverse Event Report: TORNIER INC. AEQUALIS PERFORM REVERSED SHOULDER SYSTEM; SHOULDER PROSTHESIS SCREW

Catalog Number DWJ318

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

The screws did not purchase into bone.The surgeon had to use different lengths than what was needed to secure the baseplate.Surgery was extended by an extra 15 minutes.

• Brand Name: AEQUALIS PERFORM REVERSED SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS SCREW
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue south; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 7262995
• MDR Text Key: 100137148
• Report Number: 3004983210-2018-00001
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2017

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
• Device Operator: Physician
• Device Catalogue Number: DWJ318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 02/12/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention