MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ338
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The revision surgery was conducted in response to an infection.An update provided indicates a lack of information regarding the lot numbers for the screws used.However, it was mentioned that the infection appeared to be localized, and the procedure involved washing out and exchanging parts.
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.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18784091
• Report Number: 0001649390-2024-00069
• Device Sequence Number: 12720826
• Product Code: PHX
• UDI-Device Identifier: 00846832089307
• UDI-Public: 00846832089307
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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: DWJ338
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2024
• 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 Age: 50 YR
• Patient Sex: Male