MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ401

Device Problem Positioning Failure (1158)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

During a surgical procedure, there was an issue with a standard 36mm glenosphere not securely tightening onto the baseplate, causing it to spin.After multiple attempts, a second glenosphere of the same size was successfully implanted.The problematic glenosphere has been identified with catalog number dwj012 and lot number ag2744024.The surgical delay was 5 minutes.A replacement baseplate was used and worked properly.

Manufacturer Narrative

The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

During a surgical procedure, there was an issue with a standard 36mm glenosphere not securely tightening onto the baseplate, causing it to spin.After multiple attempts, a second glenosphere of the same size was successfully implanted.The problematic glenosphere has been identified with catalog number dwj012 and lot number ag2744024.The surgical delay was 5 minutes.A replacement baseplate was used and worked properly.

• Brand Name: TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18475707
• MDR Text Key: 332443396
• Report Number: 0001649390-2024-00011
• 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,Followup
• Report Date: 03/27/2024

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 Catalogue Number: DWJ401
• Device Lot Number: 4008AZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/27/2024
• 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