MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ502
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: surgery began around 1:30 p.M.After the skin incision, it was discovered that the implant had not been prepared.Because of the time required for the implant to arrive, the wound was closed once and the instrument re-sterilized.The surgery restarted at 22:38 and finished around 23:45.The wound was closed once the situation had progressed to the arthrodesis after the head osteotomy.Upon returning to the patient's room, the patient complained of pain.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but evidences were provided based on provided information which match the alleged failure.Based on investigation, the root cause was attributed to a distribution related issue.The failure was caused by a lack of communication regarding updated set information given to the dealer (the difference between the glenoid basic set and the optional set requested for the surgery has not been considered by stryker).A report was sent to the customer by the stryker japan t&e division sales department, who took action on the matter.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that: surgery began around 1:30 p.M.After the skin incision, it was discovered that the implant had not been prepared.Because of the time required for the implant to arrive, the wound was closed once and the instrument re-sterilized.The surgery restarted at 22:38 and finished around 23:45.The wound was closed once the situation had progressed to the arthrodesis after the head osteotomy.Upon returning to the patient's room, the patient complained of pain.

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 25MM
• 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: 20510746
• Report Number: 0001649390-2024-00612
• Device Sequence Number: 18273845
• Product Code: PHX
• UDI-Device Identifier: 00846832092123
• UDI-Public: (01)00846832092123(11)240314(17)290314(21)5070BA020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: Health Professional
• Device Catalogue Number: DWJ502
• Device Lot Number: 5070BA020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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: Other
• Patient Sex: Male