MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. MALLET, 1 1/2 IN HEAD, 2 LBS WEIGHT, 7 1/2 IN

Model Number	27-0401
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "we are experiencing chunks of the head of the mallet breaking off and landing on the surgical field and in the surgical wound.The edges of the mallet head are compressing and rolling curls of metal that break off in chunks.All pieces that came off were located and did not get lost in the patient.".
Additional Manufacturer Narrative
The device was not returned for evaluation, however pictures and additional information were provided.The root cause of the compression of the mallet is normal wear and tear, along with lack of maintenance on the mallet head.Maintenance instructions were provided to the customer, to include polishing and smoothing of the device to ensure that the surfaces and edges do not get progressively sharper over time.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: MALLET, 1 1/2 IN HEAD, 2 LBS WEIGHT, 7 1/2 IN
• Common Device Name: MALLET
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 24682564
• Report Number: 3002750084-2026-00034
• Device Sequence Number: 9976999
• Product Code: LXH
• UDI-Device Identifier: 00887482063477
• UDI-Public: 00887482063477
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Model Number: 27-0401
• Device Lot Number: R003S625/26, R003S359/05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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