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

Model Number	DWJ013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Event or Problem Description
Allegedly, the patient underwent a surgical procedure on the shoulder.The screw of the glenosphere was jammed and the surgeon was not able to advance it and place it into the baseplate.By trying to advance the screw a piece broke (pictures attached).Surgeon had to proceed with a smaller size glenosphere.
Additional Manufacturer Narrative
H6: 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 moved freely in the glenosphere capture plate.The glenosphere was then assembled to a perform reversed baseplate.The screw was inserted in the baseplate and engaged as intended.The glenosphere screw was able to exit and re-enter the baseplate freely during functional testing.
Event or Problem Description
Allegedly, the patient underwent a surgical procedure on the shoulder.The screw of the glenosphere was jammed and the surgeon was not able to advance it and place it into the baseplate.By trying to advance the screw a piece broke (pictures attached).Surgeon had to proceed with a smaller size glenosphere.

• Brand Name: PERFORM REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 11711480
• Report Number: 3004983210-2021-00027
• Device Sequence Number: 4427604
• Product Code: PHX
• UDI-Device Identifier: 00846832061907
• UDI-Public: 00846832061907
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DWJ013
• Device Lot Number: CZ0220352018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1