MAUDE Adverse Event Report: TELEFLEX MEDICAL CLEANPUNCH 2.0, TFP, 8", FWD., 3 MM; RONGEUR

Model Number IPN015479

Device Problem Material Separation (1562)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Mw#5109515.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).

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.

Event Description

Mw#5109515 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).

Manufacturer Narrative

Qn# (b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.No photos were provided to support the investigation.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.No confirmed complaints were received in this range with the same issue.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km59316.Root cause not established- no sample provided.The sample will be reinvestigated if received.

• Brand Name: CLEANPUNCH 2.0, TFP, 8", FWD., 3 MM
• Type of Device: RONGEUR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14644897
• MDR Text Key: 301529964
• Report Number: 3011137372-2022-00095
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 24026704289190
• UDI-Public: 24026704289190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN015479
• Device Catalogue Number: KM59316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1