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

Catalog Number DWJ502

Device Problems Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The baseplate initially couldn't accommodate the center compression screw.Efforts were made to reset the spacer, but it didn't work with the t20 driver or a long-handled screwdriver.After multiple unsuccessful attempts, an alternative baseplate was used.The reporter attempted to reset the spacer after the procedure but couldn't get the screw to fit properly.It's believed that the spacer in the baseplate was meant for a +6mm baseplate.The issue happened during a primary reverse, involving a 6.5 30 screw (dwj130), and it was ultimately resolved by switching to a different baseplate.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.H3 other text : device disposition is unknown.

• 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: 17750366
• MDR Text Key: 323625006
• Report Number: 0001649390-2023-00232
• 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

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DWJ502
• Device Lot Number: 1756123013
• Was Device Available for Evaluation?: No
• Date Manufacturer 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female