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 05/10/2023

Event Type  malfunction  

Event Description

During the patient's procedure, the surgeon attempted to insert a 6.5 center screw into the baseplate, but it got stuck on the inner threads of the baseplate, preventing it from advancing to the correct position.Trying a different screw yielded the same results.Subsequently, the surgeon opened a new baseplate, and without any issues, the screw properly engaged with the baseplate.This event occurred during a primary surgery.There was no debris reported, and if any had been present, it was successfully removed from the surgical field or the patient.

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 discarded.

• 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: 17750367
• MDR Text Key: 323490066
• Report Number: 0001649390-2023-00233
• 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: Health Professional
• Reporter Occupation: Physician
• 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: Health Professional
• Device Catalogue Number: DWJ502
• Device Lot Number: 1756123011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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