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	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During revision surgery, the peripheral and sphere screwdriver snapped within the central screw of the baseplate.The baseplate inserter screwdriver also fractured.Because the fragment was lodged and could not be removed using the standard technique, the surgical team pivoted to an alternative method for baseplate removal.During this process, the baseplate inserter handle broke.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction: d9 product return, h6 (method and health impact) code.The reported event was confirmed, as the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection of the returned device confirmed a structural failure at the distal end, with the screwdriver tip exhibiting an oblique fracture pattern.The fracture presents a predominantly planar shear surface, indicating a brittle fracture.The oblique plane and smooth fibrous texture suggest failure caused by sudden high mechanical force.Additionally, circular gouge marks were observed along the shaft, consistent with prolonged or repeated use.Overall findings suggest significant mechanical loading prior to failure.Additionally, a hardness test revealed the device met the required specification.Based on the investigation, the root cause was attributed to a combination of user-related factors.The event was caused by mechanical overload, as evidenced by the blunt, abrupt fracture from off-axis use, along with scratches indicating excessively rough use and mishandling.A review of the device history record 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 issues were identified during the investigation.If additional information becomes available, the case will be reassessed.
Event or Problem Description
During revision surgery, the peripheral and sphere screwdriver snapped within the central screw of the baseplate.The baseplate inserter screwdriver also fractured.Because the fragment was lodged and could not be removed using the standard technique, the surgical team pivoted to an alternative method for baseplate removal.During this process, the baseplate inserter handle broke.

• 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: 23803485
• Report Number: 0001649390-2025-00941
• Device Sequence Number: 9297341
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: (01)00846832062461(11)240801(10)AZ2122347
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/05/2026

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: AZ2122347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 76 YR
• Patient Sex: Male