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

Catalog Number	MWJ123
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Surgeon was inserting baseplate into glenoid when he encountered very hard born.Excessive torque was needed to turn the screw, at which point the tip of the driver broke off and was retained in the head of the center screw.Glenosphere was able to attach just fine, and the case proceeded as planned.
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 the following: the visual inspection of the returned device suggests shows breakage at the driver tip.The fracture patterns suggest application of non-axial tortional load resulting in instantaneous breakage.The returned instrument exhibited significant wear, including scratches & discoloration along the shaft.Furthermore, cracks around the press fit pin in the plastic handle were also observed.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification 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 normal wear related issue.The device has been in use since 2018 and has been subjected to repeated torsional loading along with multiple cleaning and reprocessing cycles.The combined effect of these factors likely led to alteration and degradation of the material properties over time if more information is provided, the case will be reassessed.
Event or Problem Description
Surgeon was inserting baseplate into glenoid when he encountered very hard born.Excessive torque was needed to turn the screw, at which point the tip of the driver broke off and was retained in the head of the center screw.Glenosphere was able to attach just fine, and the case proceeded as planned.

• 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 ; 2018315000
• MDR Report Key: 24121028
• Report Number: 0001649390-2026-00047
• Device Sequence Number: 5987310
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: (01)00846832062461(11)180426(10)AZ1918017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: AZ1918017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• 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