MAUDE Adverse Event Report: HU-FRIEDY MANUFACTURING 11 STRAIGHT BERNARD SYNDESMOTOME; SPADE ELEVATOR

Model Number BER 11

Device Problem Material Fragmentation (1261)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/04/2023

Event Type  malfunction  

Event Description

During dental extraction of tooth instrument fractured at the tip forcing instrument posteriorly into the right tonsil causing a puncture wound.Tip of instrument was identified and removed from the oral cavity.No foreign body retained or swallowed.

• Brand Name: 11 STRAIGHT BERNARD SYNDESMOTOME
• Type of Device: SPADE ELEVATOR
• Manufacturer (Section D): HU-FRIEDY MANUFACTURING; chicago IL
• MDR Report Key: 17949558
• MDR Text Key: 325841037
• Report Number: 17949558
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2023

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: BER 11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/14/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native