MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ738
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, during a reverse shoulder replacement at the the stage of implanting the peripheral screws, the consultant attempted to remove the 38mm dwj738 screw in order to replace it with a smaller size.While the screw was being removed from the baseplate, the screw snapped.The break occurred with part of the screw remaining embedded inside the baseplate, positioned within the patient¿s glenoid.Due to the nature of the breakage, it was not possible to extract the remaining portion of the screw from either the baseplate or the patient¿s glenoid.As a result, the retained fragment had to be left in situ.
Event or Problem Description
It was reported that, during a reverse shoulder replacement at the stage of implanting the peripheral screws, the consultant attempted to remove the 38mm dwj738 screw in order to replace it with a smaller size.While the screw was being removed from the baseplate, the screw snapped.The break occurred with part of the screw remaining embedded inside the baseplate, positioned within the patient¿s glenoid.Due to the nature of the breakage, it was not possible to extract the remaining portion of the screw from either the baseplate or the patient¿s glenoid.As a result, the retained fragment had to be left in situ.
Additional Manufacturer Narrative
Correction to clinical sign code: corrected from foreign body in patient to no clinical signs or symptoms, and the health impact code was corrected from minor injury to blank.The other code was retained.The reported event could not be confirmed since the device was not returned for evaluation, and no other evidence was provided.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-, manufacturing-, or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM STERILE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23817124
• Report Number: 0001649390-2025-00944
• Device Sequence Number: 9386736
• Product Code: PHX
• UDI-Device Identifier: 00846832091270
• UDI-Public: (01)00846832091270(11)240815(17)290815(21)AG9768026
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: DWJ738
• Device Lot Number: AG9768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown