MAUDE Adverse Event Report: TORNIER S.A.S. ASCEND FLEX STANDARD STEM COMPACTOR SIZE 1; INSTRUMENT, COMPRESSION

Catalog Number	MWF601S
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspection of the instrument tray at the warehouse, blood and/or bone residue was found inside an instrument.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that upon inspection of the instrument tray at the warehouse, blood and/or bone residue was found inside an instrument.
Additional Manufacturer Narrative
The reported event was not confirmed on the returned device.The device inspection revealed the following: visual inspection.The received device shows no presence of any bio matter on to the surface and/or into the grooves of stem.However, the device is extensively used as evident by wear, scratches, discoloration and faded laser markings.Overall damage indicates heavy and rough usage.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 reported issue is not confirmed.However further use of the device is not recommended as device is worn out due to extensive usage.A scope of improvement is in progress to prevent the recurrence of the event.If more information is provided, the case will be reassessed.
Additional Manufacturer Narrative
Correction: fda registration number 3000931034 - te (mtbonnot).D3.Manufacturer entity.G1.Manufacturing site.
Event or Problem Description
It was reported that upon inspection of the instrument tray at the warehouse, blood and/or bone residue was found inside an instrument.

• Brand Name: ASCEND FLEX STANDARD STEM COMPACTOR SIZE 1
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23584413
• Report Number: 0001649390-2025-00835
• Device Sequence Number: 9222960
• Product Code: HWN
• UDI-Device Identifier: 03700386977107
• UDI-Public: (01)03700386977107(11)230406(10)DR0722285
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/17/2026

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: MWF601S
• Device Lot Number: DR0722285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/13/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/03/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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