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

Catalog Number DWJ502

Device Problems Mechanical Problem (1384); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event could be confirmed.The device was returned for evaluation and found to be in the condition noted in the event details.Visual inspection: a visual inspection revealed the part was assembled incorrectly.The correct lock spacer for this assembly should be cd-6137-01 size 3.5mm.It was assembled with lock spacer cd-6137-02 size 6mm.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.Indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the event involved a product problem indicating a non-conformity, adverse trend, or unanticipated hazard due to a manufacturing issue which has been elevated to an nc to investigate further and determine the root cause of the event.If any additional information is provided, the investigation will be reassessed.

Event Description

The physician attempted to insert the center screw into the baseplate, but it wouldn't advance.Trying a different screw had the same result.Eventually, a new baseplate was used, and it worked without any issues.The procedure, which involved reverse central screw, peripheral screws, and glenosphere, was planned with the problematic baseplate, but it couldn't be used because the central screw couldn't be threaded all the way into the baseplate.

• Brand Name: TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM
• Type of Device: 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: 17750365
• MDR Text Key: 323487751
• Report Number: 0001649390-2023-00234
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092123
• UDI-Public: 00846832092123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWJ502
• Device Lot Number: 1756123008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1