MAUDE Adverse Event Report: TORNIER S.A.S. BLUEPRINT SOFTWARE; SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number BPUE001

Device Problems Off-Label Use (1494); Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2021

Event Type  malfunction  

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 in a supplemental report.

Event Description

As reported: "blueprint software allowed users to plan surgeries using incompatible (not approved) configurations".

• Brand Name: BLUEPRINT SOFTWARE
• Type of Device: SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19067684
• MDR Text Key: 340465783
• Report Number: 3000931034-2024-00195
• Device Sequence Number: 1
• Product Code: QHE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K232265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

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: BPUE001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1