MAUDE Adverse Event Report: TORNIER INC ASCEND FLEX STANDARD STEM COMPACTOR SIZE 1; PROSTHESIS, SHOULDER, HEMI, HUMERAL, METALLIC UNCEMENTED

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	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Upon inspection of tray at warehouse, blood/bone found inside of instrument.
Additional Manufacturer Narrative
Correction - the fda registration number is (b)(6).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The received device after decontamination shows the presence of contamination due to dry blood on top of the compactor surface.No presence of any bio matter into the grooves is observed.However, the device is extensively used as evident by wear, scratches, discoloration, abrasion marks and faded laser markings for the inclination angle.Overall damage indicates frequent 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 the investigation, the root cause of the event was determined to be related to wear issues.The device in question has experienced extensive usage over time, which contributed significantly to the problem as it was manufactured in 2020.A scope of improvement is in progress to prevent the recurrence of the event.If more information is provided, the case will be reassessed.
Event or Problem Description
Upon inspection of tray at warehouse, blood/bone found inside of instrument.

• Brand Name: ASCEND FLEX STANDARD STEM COMPACTOR SIZE 1
• Common Device Name: PROSTHESIS, SHOULDER, HEMI, HUMERAL, METALLIC UNCEMENTED
• 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: 23576248
• Report Number: 0001649390-2025-00830
• Device Sequence Number: 18467717
• Product Code: HSD
• UDI-Device Identifier: 03700386977107
• UDI-Public: (01)03700386977107(10)DR1520070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• 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): 03/03/2026

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: Other
• Device Catalogue Number: MWF601S
• Device Lot Number: DR1520070
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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