MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ505

Device Problem Mechanical Jam (2983)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition unknown.

Event Description

During the assembly of baseplate with a central screw, the screw was found to be limited and unable to thread completely into the baseplate.A replacement screw was attempted, but the same issue persisted.As a result, the baseplate became unusable, necessitating the opening of a larger size to complete the operation.

Event Description

During the assembly of baseplate with a central screw, the screw was found to be limited and unable to thread completely into the baseplate.A replacement screw was attempted, but the same issue persisted.As a result, the baseplate became unusable, necessitating the opening of a larger size to complete the operation.

Manufacturer Narrative

Corrections: h6 health impact code, d9 product available to stryker, d4 serial #.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 received device shows no obvious signs of wear or damage.Visually, the device is in good condition for use.However,in a functional test, it was observed that the baseplate could not engage well with the screw and the screw would not seat completely.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 & 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 assess the issue.If any further information is provided, the complaint report will be updated.

Manufacturer Narrative

This supplemental is to make note of the fact that the initial mdr was not needed as the event was reported in error.

Event Description

During the assembly of baseplate with a central screw, the screw was found to be limited and unable to thread completely into the baseplate.A replacement screw was attempted, but the same issue persisted.As a result, the baseplate became unusable, necessitating the opening of a larger size to complete the operation.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG 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: 18822783
• MDR Text Key: 336886172
• Report Number: 0001649390-2024-00079
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092109
• UDI-Public: 00846832092109
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 07/08/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWJ505
• Device Lot Number: 9134AZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 05/08/2024; 06/12/2024
• Supplement Dates FDA Received: 06/05/2024; 07/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2023
• 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