MAUDE Adverse Event Report: OSTEOMED, LLC QUICK CONNECT RECIPROCATING SAW; HANDPIECE, ROTARY BONE CUTTING

Model Number	450-0241
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause could not be established.Additional reporting on this event will be provided as a follow up report if more information becomes available.
Event or Problem Description
It was reported that when they used the saw for the first case after receiving it, the handpiece was completely broken.No delay or adverse events were reported.

• Brand Name: QUICK CONNECT RECIPROCATING SAW
• Common Device Name: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: kimberly banning ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 23098028
• Report Number: 2027754-2025-00049
• Device Sequence Number: 9225874
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: 00845694037167
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: 450-0241
• Device Catalogue Number: 450-0241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown