MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER

Model Number	32-2816
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, a metal flake from their snowden-pencer diamond-tip wire/pin cutter fell into the patient.The metal flake was immediately removed from the patient and the area was irrigated.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
V.Mueller has requested the device subject of the reported event be returned for evaluation.The snowden-pencer diamond-tip wire/pin cutter instructions for use states, "inspection/maintenance: inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts.If any of these conditions appear, do not use the device.Return devices to an authorized repair service center for repair or replacement." a 3-year complaint review indicates this to be an isolated event.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The snowden-pencer diamond-tip wire/pin cutter was returned to the supplier, xka - kapp surgical gmbh for evaluation.The evaluation indicated that three chippings were noted on the cutting edge of the device.A specific root cause could not be determined.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER
• Common Device Name: WIRE/PIN CUTTER
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 17958213
• Report Number: 1423507-2023-00104
• Device Sequence Number: 12523607
• Product Code: HXZ
• UDI-Device Identifier: 10885403146060
• UDI-Public: 10885403146060
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 32-2816
• Device Lot Number: K22XKA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown