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

Model Number 1780-02

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2022

Event Type  malfunction  

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 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 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.

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.
• Type of Device: 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
• MDR Text Key: 289320540
• Report Number: 1833053-2022-00001
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 00840277101952
• UDI-Public: 00840277101952
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1780-02
• Device Catalogue Number: 1780-02
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG