MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. OMNI; DRILL

Catalog Number	144-00032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the omni fenestrating drill (p/n 144-00032) broke off in the patient intraoperatively.The broken piece was left in the patient.The surgery was otherwise successful and there were no patient effects reported.

• Brand Name: OMNI
• Common Device Name: DRILL
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: mary hoffman ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07504 ; 9735888980
• MDR Report Key: 21129255
• Report Number: 3007289093-2025-00001
• Device Sequence Number: 7464545
• Product Code: HTW
• UDI-Device Identifier: 00842078116128
• UDI-Public: (01)00842078116128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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 Catalogue Number: 144-00032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/10/2025
• 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