MAUDE Adverse Event Report: INNOMED, INC. INNOMED, INC.; RONGEUR

Model Number	1780-02
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receipt of the report, innomed contacted the initial reporter at the user facility and requested that the affected device be returned for investigation and an evaluation.The user facility never responded.Innomed's internal capa and complaints databases were surveyed for the same issue with the part.No entries were found in the capa database.Two entries were found in the complaints database regarding the part, but the described issues of the aforementioned entries were not the same as the described issue of the part referenced in this report.Innomed will again reach out to the initial reporter for additional information and provide a follow up.
Event or Problem Description
Rongeur with an angled handle had a screw fall out during surgery.An x-ray was taken immediately to verify that no foreign pieces from the rongeur were retained.The instrument was then removed from the sterile field.
Event or Problem Description
Rongeur with an angled handle had a screw fall out during surgery.An x-ray was taken immediately to verify that no foreign pieces from the rongeur were retained.The instrument was then removed from the sterile field.
Additional Manufacturer Narrative
Innomed reached out to the user facility and again requested that the affected device returned.Contact at the user facility responded that the item could not be located.Results of the two (2) surveys referenced in the initial report regarding the part number determined the issues to be the result of misuse.Because of the aforementioned statement, innomed was not able to procure the affected part for inspection and evaluation.The described issue for the affected part is the first of its kind.Innomed will trend this issue to determine if corrective measures are required.

• Brand Name: INNOMED, INC.
• Common Device Name: RONGEUR
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31405
• Manufacturer (Section G): INSTRUMENTAL MACHINE AND DEVELOPMENT; 2098 n. pound drive w.; warsaw IN 46582
• Manufacturer Contact: irene davis ; 103 estus drive; savannah, GA 31404 ; 9122360000
• MDR Report Key: 13688946
• Report Number: 1833053-2022-00001
• Device Sequence Number: 14822732
• Product Code: HWB
• UDI-Device Identifier: 00840277101952
• UDI-Public: 00840277101952
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 1780-02
• Device Catalogue Number: 1780-02
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/09/2022
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG