MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 9.5MMX30MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
The implants involved in the failure were from tornier.The glenoid baseplate failed four weeks post-operation, possibly due to a fall.All tornier implants were removed.An update reveals that a 25mm full wedge baseplate with a 30mm 9.5mm central screw was removed, and the failure was not attributed to hardware.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 9.5MMX30MM NON STERILE
• Common Device Name: 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: 18908717
• Report Number: 0001649390-2024-00115
• Device Sequence Number: 6248431
• Product Code: PHX
• UDI-Device Identifier: 00846832088607
• UDI-Public: 00846832088607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown