MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; ORTHOPAEDIC MALLET

Model Number	OS1519
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during patient procedures pieces of metal were "flecking off" of their orthopaedic mallet.No report of injury.
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.Upon evaluation, it was found that pieces of metal were coming off the device.The likely cause of the reported event is attributed to wear and tear of the instrument over time.The device subject of the reported event was manufactured in 2016 and is approximately nine years old.The instrument was permanently removed from service.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: ORTHOPAEDIC MALLET
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 22153992
• Report Number: 1527821-2025-00008
• Device Sequence Number: 15324476
• Product Code: GFJ
• UDI-Device Identifier: 10885403188305
• UDI-Public: (01)10885403188305(10)XSSZ09
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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 Model Number: OS1519
• Device Catalogue Number: OS1519
• Device Lot Number: (10)XSSZ09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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