MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ012

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 returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received device(glenosphere) when inspected visually looks in good condition and shows no signs of damage.Moreover, the functional inspection was done by assembling the glenosphere with the sample baseplate and it was observed the baseplate stays fixed to the glenosphere after tightening.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 must be available in order to determine the exact root cause of the complaint event.If any further information is provided, the complaint report will be updated.

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 STANDARD GLENOSPHERE DIA 36MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18475702
• MDR Text Key: 332775859
• Report Number: 0001649390-2024-00010
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832090334
• UDI-Public: 00846832090334
• 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: DWJ012
• Device Lot Number: AG2744024
• 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
• Date Device Manufactured: 09/06/2023
• 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