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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
An issue arose with a baseplate where the central screw wouldn't fully engage.Fortunately, this didn't affect the patient or surgery due to having a backup available.The incident occurred during a primary reverse surgery.There was a brief delay to resolve the issue and obtain another baseplate.
Event or Problem Description
An issue arose with a baseplate where the central screw wouldn't fully engage.Fortunately, this didn't affect the patient or surgery due to having a backup available.The incident occurred during a primary reverse surgery.There was a brief delay to resolve the issue and obtain another baseplate.
Additional Manufacturer Narrative
The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection was performed on returned device and revealed no obvious signs of wear or damage and spacer location is incorrect.The functional test was performed and it was observed that the reported device has two spacers.There supposed to be only one spacer assembled in the product, due to which the central screw is not able to seat on the baseplate properly.Hence, the reported event is confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a manufacturing related issue.Hence, the nonconformance is initiated to further access the issue.If any further information is provided, the complaint report will be updated.

• 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: 18965631
• Report Number: 0001649390-2024-00123
• Device Sequence Number: 15494198
• Product Code: PHX
• UDI-Device Identifier: 00846832092123
• UDI-Public: 00846832092123
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 05/20/2024

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: Lay User/Patient
• Device Catalogue Number: DWJ502
• Device Lot Number: CZ3923353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sex: Unknown