MAUDE Adverse Event Report: TELEFLEX MEDICAL KMEDIC CLEANPUNCH KERRISON RONGEUR 3MM

Model Number KM-59-316 3MM

Device Problem Break (1069)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

During the spinal procedure, a pin came out of the 3mm kerrison rongeur.An x-ray was performed to rule out retained pin.The pin was then located outside the patient on the sterile field.Staff report that this was the second instance of these k medic kerrison rongeurs losing their pins.Staff also report there were instances of sticking or freezing during use with this instrument set.Fda safety report id# (b)(4).

• Brand Name: KMEDIC CLEANPUNCH KERRISON RONGEUR 3MM
• Type of Device: RONGEUR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 14282847
• MDR Text Key: 290802261
• Report Number: MW5109515
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KM-59-316 3MM
• Device Catalogue Number: KM-59-316 3MM
• 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