MAUDE Adverse Event Report: SYMMETRY SURGICAL RAPIDCLEAN KERRISON RONGEUR; RONGEUR, MANUAL

Model Number 58-3230-BD

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

During surgery, anterior cervical discectomy & fusion c4-5,c5-6,c-7, 9 inch ¿kerrison" fell apart.

• Brand Name: RAPIDCLEAN KERRISON RONGEUR
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• MDR Report Key: 15502794
• MDR Text Key: 300794079
• Report Number: 15502794
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-3230-BD
• Device Catalogue Number: 58-3230-BD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Sex: Male