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

Model Number	IPN015479
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem 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).
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem 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).
Additional Manufacturer Narrative
(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 km59316.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
• Common Device Name: 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: 14633717
• Report Number: 3011137372-2022-00096
• Device Sequence Number: 4833003
• Product Code: HTX
• UDI-Device Identifier: 24026704289190
• UDI-Public: 24026704289190
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN015479
• Device Catalogue Number: KM59316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown