MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED STANDARD INSERT 42MM X 6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWB996
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
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 in a supplemental report.
Event or Problem Description
As reported: "the delivery of loaner kits # 2090431704 took place without any problem notification - complete implants & instruments.However, after checking the kit on site, it was found that the dwb996 implant was missing and the dwd082 implant was included twice.As a result, a compromised solution had to be found during the operation where dwb996 was actually required (but not available) with the use of a different inlay".
Event or Problem Description
As reported: "the delivery of loaner kits # 2090431704 took place without any problem notification - complete implants and instruments.However, after checking the kit on site, it was found that the dwb996 implant was missing and the dwd082 implant was included twice.As a result, a compromised solution had to be found during the operation where dwb996 was actually required (but not available) with the use of a different inlay".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned (product missing in the kit).A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on investigation, the root cause was attributed to a distribution related issue (incorrect-improper handling for a kit sent to a customer).In order to address the issue, an nc has been opened to investigate further and prevent its recurrence.If any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED STANDARD INSERT 42MM X 6MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19697405
• Report Number: 3000931034-2024-00361
• Device Sequence Number: 15242665
• Product Code: PHX
• UDI-Device Identifier: 03700386916571
• UDI-Public: 03700386916571
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050316
• 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): 09/25/2024

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
• Operator of Device: Other
• Device Catalogue Number: DWB996
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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
• Patient Sex: Unknown