MAUDE Adverse Event Report: Tornier Inc TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20; Screwdriver

Catalog Number	MWJ123
Medical Device Problem Codes	Corroded (1131); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of driver broke off while in use (tightening the glenosphere).Broken tip removed from implant, 5-minute delay of case.No debris reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed, a visual examination of the returned device shows clear breakage, primarily concentrated at the tip of the driver.The damage pattern strongly suggests that the hexagonal screwdriver was repeatedly exposed to significant torque forces applied at an off axis angle.In addition, multiple corrosion spots are evident within the material, likely penetrating through micro cracks.This is consistent with longterm use of the device, involving repeated cleaning and sterilization cycles.The fracture has resulted in multiple broken pieces, indicating a brittle failure mode.Moreover, a hardness test values indicate the material being within the limit with the accordance range.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused due to repeated application of high, off axis torque that generated localized stress concentrations at the hex interface, initiating micro cracks that propagated under cyclic loading.Over time, corrosive ingress through these cracks exacerbated by repeated cleaning and sterilization cycles.Accelerated crack growth and reduced material toughness, culminating in a brittle, multi piece fracture.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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50898909
• Report Number: 0001649390-2026-00998
• Device Sequence Number: 6037605
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: (01)00846832062461(10)AZ3418113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: MWJ123
• Device Lot Number: AZ3418113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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