MAUDE Adverse Event Report: TORNIER INC PERFORM PERIPHERAL PLANER SZ 4; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWM044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
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: visual inspection: the returned device shows clear signs of physical damage.The plastic insert has fractured and separated from the metal cross pin of the planer body.A small fragment of the insert remains lodged between the cross pin and the planer housing.No additional damage is observed on the metal body.The insert appears severely compromised, with a breakage pattern suggesting brittleness likely caused by significant mechanical force.Visible discoloration on the insert may be due to oxidation from contact with the metal component.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.Most likely, the event was caused by application of high mechanical forces leading to failure noted in the event.If more information is provided, the case will be reassessed.
Event or Problem Description
The centering tip of the reamer came off while the surgeon was reaming the humerus.Broken piece was removed.

• Brand Name: PERFORM PERIPHERAL PLANER SZ 4
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 23478008
• Report Number: 0001649390-2025-00794
• Device Sequence Number: 21472295
• Product Code: HWE
• UDI-Device Identifier: 00846832082735
• UDI-Public: (01)00846832082735(10)19781520
• 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
• Report Date (Section B): 11/05/2025

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: MWM044
• Device Lot Number: 19781520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• 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
• Patient Sex: Unknown