MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 32MM HEADLESS SCREW; SCREW, FIXATION, BONE

Model Number	317-2032
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, 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 the screw snapped in the middle while the surgeon was implanting it , the surgeon then took out the piece that broke and the reduction was still holding so he left it.The fracture was still reduced and no further complications were reported and thus no further intervention was needed.No delay reported.
Additional Manufacturer Narrative
The product was received and examined on november 04, 2025.The screw broke at the end of proximal part of the lag portion, and it shows a slight bent on the region, but root cause determination can be made.

• Brand Name: 2.0MM X 32MM HEADLESS SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 23293089
• Report Number: 2027754-2025-00051
• Device Sequence Number: 10028022
• Product Code: HWC
• UDI-Device Identifier: 00845694027090
• UDI-Public: 00845694027090
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K063298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 317-2032
• Device Catalogue Number: 317-2032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female