MAUDE Adverse Event Report: TORNIER INC PERFORM 135 DG IM CUT GUIDE BLOCK; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	MWX135
Medical Device Problem Codes	Material Erosion (1214); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, repeatedly, the insertion of the guide wire into the mwx135 ¿ im cutting block, 135°, has resulted in metal abrasion at one of the guide-wire entry holes.Metal particles had to be removed manually from the surgical site.Metal particles may remain in the surgical site, posing an infection risk due to foreign material.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, repeatedly, the insertion of the guide wire into the mwx135 ¿ im cutting block, 135°, has resulted in metal abrasion at one of the guide-wire entry holes.Metal particles had to be removed manually from the surgical site.Metal particles may remain in the surgical site, posing an infection risk due to foreign material.
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 evidence of heavy wear across the body of the device, primarily in the form of surface discoloration.Notably, deformation is present along the edge of the 0 wire guide hole on the cut guide.The material in this area appears plastically deformed, consistent with the repeated insertion and removal of the guide wire.Due to the nature of the returned instrument, a dimensional inspection was not possible since a measurable feature is deformed.However, during manufacturing, functionality testing and dimensional inspection were performed according to specifications.During inspection, all devices met the specifications.Based on the investigation, the root cause was attributed to a user and wear related issue.The event was caused by cumulative mechanical wear from repeated use and was exacerbated by off-axis loading of the guide wire by the end user.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: PERFORM 135 DG IM CUT GUIDE BLOCK
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 23975788
• Report Number: 0001649390-2026-00020
• Device Sequence Number: 21508954
• Product Code: KWT
• UDI-Device Identifier: 00846832082377
• UDI-Public: (01)00846832082377(10)19780502
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MWX135
• Device Lot Number: 19780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown