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

Catalog Number	DWJ502
Medical Device Problem Codes	Mechanical Problem (1384); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: 17750367
• Report Number: 0001649390-2023-00233
• Device Sequence Number: 7519955
• Product Code: PHX
• UDI-Device Identifier: 00846832092123
• UDI-Public: 00846832092123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: DWJ502
• Device Lot Number: 1756123011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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