MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 6.5MMX40MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a revision surgery.Patient had shown signs of infection and was draining from the healed incision site.No instability was reported or observed.Cultures were performed intraoperatively.The patients 3yr old wound was draining for the last 3-4 weeks and the doctor decided to remove all the implants and implant an antibiotic spacer.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 6.5MMX40MM NON STERILE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24482703
• Report Number: 0001649390-2026-00207
• Device Sequence Number: 20078540
• Product Code: PHX
• UDI-Device Identifier: 00846832089895
• UDI-Public: 00846832089895
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: DWJ140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 75 YR
• Patient Sex: Male