MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION RONGEUR; LUER RONGEUR

Model Number JARIT 230-261

Device Problem Break (1069)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

Dr using rongeur instrument inside pt.When one side of bite broke off.A small piece of metal was recovered but doesn't look like the full piece that broke off.Checked all raytec for any additional metal, none found, had xray take pictures and sent to radiology to see if any metal can be found and confirmed with cell saver that if piece of metal was sucked up that it would be stopped at filter when blood was spun down.Operating room manager called into room, and instrument and piece of metal taken to risk management by operating room manager.

• Brand Name: RONGEUR
• Type of Device: LUER RONGEUR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 16043162
• MDR Text Key: 306323774
• Report Number: MW5113964
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2023
• Device Model Number: JARIT 230-261
• Device Lot Number: 56-1302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose