MAUDE Adverse Event Report: TORNIER S.A.S. BLUEPRINT REVERSED GLENOID GUIDE AND GLENOID BONE MODEL MWJ013; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	MWJ004
Medical Device Problem Codes	Component Missing (2306); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wrong psi guide was put into the box.Surgeon had already started the operation and had to proceed without this planned psi.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not available.
Additional Manufacturer Narrative
The reported event could be confirmed based on the information provided by the manufacturing site.A device inspection was not possible since the affected devices were not returned.However, the reported event of mixing-up of psi guides during packaging was confirmed by the manufacturing site based on evidence received from the customer.The surgeon did not receive the psi guide and the bone model ordered for the surgery (lot # 1rvr00yh).He received a guide and a bone model of a different surgery, with a different patient id and case id (lot # 1rvr00th).The devices inside the packaging did not correspond to what was indicated on the packaging label (which contained the information of the devices ordered by the surgeon).Based on investigation, the root cause was attributed to a packaging related issue.The failure was caused by confusion during the packaging process.The devices in question have the same catalog number and have a very similar lot number.This lead to the devices being mixed-up.The devices of lot # 1rvr00th were put inside the packaging intended for devices lot # 1rvr00yh and vice versa.A nc and a capa were initiated to cover this issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the wrong psi guide was put into the box.Surgeon had already started the operation and had to proceed without this planned psi.

• Brand Name: BLUEPRINT REVERSED GLENOID GUIDE AND GLENOID BONE MODEL MWJ013
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 17737874
• Report Number: 3000931034-2023-00280
• Device Sequence Number: 5493297
• Product Code: KWS
• UDI-Device Identifier: 93700386998976
• UDI-Public: 93700386998976
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162800
• 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): 11/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2024
• Device Catalogue Number: MWJ004
• Device Lot Number: 1RVR00Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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
• Patient Sex: Unknown