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

Model Number DWJ125

Device Problems Use of Device Problem (1670); Mechanical Jam (2983)

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

Event Date 10/23/2020

Event Type  Injury  

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

Allegedly, during insertion of the screw into the baseplate the bone was too hard.The surgeon attempted to remove the screw to exchange for a post but was unable to remove.The surgeon removed the baseplate and put in new implants.There was a 45 minute increase to or time.

• Brand Name: 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: 10856557
• MDR Text Key: 216838963
• Report Number: 3004983210-2020-00043
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

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: DWJ125
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR