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

Model Number 1780-02

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

Rounger 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 rounger were retained.The instrument was then removed from the sterile field.

Event Description

Rounger 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 rounger were retained.The instrument was then removed from the sterile field.

• Brand Name: INNOMED, INC.
• Type of Device: EXTRACTOR
• Manufacturer (Section D): INNOMED, INC.; 103 estus dr; savannah GA 31404
• MDR Report Key: 13583967
• MDR Text Key: 285990654
• Report Number: 13583967
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male
• Patient Weight: 81 KG