MAUDE Adverse Event Report: INNOMED, INC. UNGER CANAL FINDER RASP CURVED; RASP, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	3004-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter is not identified, and there is no contact information available to send a request for return of the device for inspection and evaluation.The user facilty is also not listed.The internal complaints and capa databases will be surveyed for similar issues associated with the referenced device.A summary will be included in the follow up report.
Event or Problem Description
It was reported that rasp became stuck in femur.Surgeon applied more force and the handle separated from rasp.This report reflects information received by fda in the form of a notification.Procedure: total hip replacement.

• Brand Name: UNGER CANAL FINDER RASP CURVED
• Common Device Name: RASP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31404
• Manufacturer Contact: anthony lozano ; 201 s towerview dr.; columbia city, IN 46725 ; 2602447677
• MDR Report Key: 19442052
• Report Number: 1833053-2024-00002
• Device Sequence Number: 18227385
• Product Code: GAC
• UDI-Device Identifier: 00840277104960
• UDI-Public: 00840277104960
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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
• Device Model Number: 3004-01
• Device Catalogue Number: 3004-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 06/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown