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

Model Number MWJ127

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the driver tip broke off during use.No patient impact.

Manufacturer Narrative

H6: he device was returned for investigation and found to be in the condition described in the event description.A visual inspection found the device exhibits obvious signs of breakage at the tip of the device.

• Brand Name: PERFORM REVERSED
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 10419793
• MDR Text Key: 203318969
• Report Number: 3004983210-2020-00020
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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
• Device Operator: Health Professional
• Device Model Number: MWJ127
• Device Lot Number: CR0119009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 09/17/2020
• Patient Sequence Number: 1