MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20; SCREWDRIVER

Catalog Number	MWJ123
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is going to be returned.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the doctor was using the long white screwdriver to remove a screw and the tip of the screwdriver snapped off.
Event or Problem Description
It was reported that the doctor was using the long white screw driver to remove a screw and the tip of the screwdriver snapped off.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure mode.The device inspection revealed the following: a visual inspection of the returned instrument shows a twisting deformation of the flutes on the torx driver end of the screwdriver.Additionally, the metal shaft portion of the screwdriver is broken and moving loosely and freely in the white plastic handle of the device.A functional and dimensional inspection of the returned instrument was not considered necessary or possible as a functional and measurable feature of the instrument is deformed and broken rendering it non-functional.Additionally, when hardness testing was done on the instrument it was slightly out of specification.However, during manufacturing, functionality tests, dimensional inspection, and material testing were done according to specifications.During the manufacturing inspections, all devices met the specifications.Based on investigation, the root cause was attributed to a user and wear related issue.The event was caused by several reprocessing cycles over the years weakening the material in the instrument in additional of heavy use and excessive torsional forces by the end user causing deformation and breakage.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20
• Common Device Name: SCREWDRIVER
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21954087
• Report Number: 0001649390-2025-00306
• Device Sequence Number: 8547628
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: (01)00846832062461(10)AZ1817145
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 07/07/2025

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: MWJ123
• Device Lot Number: AZ1817145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown