MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ012

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation and found not to be in the condition as described in the event description.Upon inspection, the glenosphere locking screw was secure in capture plate but was easily loosened.The glenosphere was then assembled to two separate perform reversed baseplates.The screw was inserted in each baseplate and engaged as intended.The glenosphere screw was able to exit and re-enter each baseplate freely during functional testing.

Event Description

Allegedly, the glenosphere would not attach to the baseplate during the case.Another glenosphere was used and attached right away to the baseplate.This caused an additional hour of surgery time.No patient complications were reported.

• Brand Name: AEQUALIS PERFORM REVERSED
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: andrew melchiori ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 11266666
• MDR Text Key: 229865715
• Report Number: 3004983210-2021-00009
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DWJ012
• Device Lot Number: CZ262004502B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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