MAUDE Adverse Event Report: SHUKLA / S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL SHUKLA MINI UNIVERSAL REMOVAL-3M; EXTRACTOR

Model Number SXT004

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

One of the four prongs from the shukla mini universal removal - 3mm extractor broke off during surgery and had to be retrieved from the patient.The extractor was being used to remove a broken 4.5mm cannulated screw from a fracture site, the extractor was unable to remove the broken screw from the patient.

• Brand Name: SHUKLA MINI UNIVERSAL REMOVAL-3M
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SHUKLA / S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
• MDR Report Key: 18093678
• MDR Text Key: 327745341
• Report Number: MW5147907
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXT004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White