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

Model Number 32-2816

Device Problem Flaked (1246)

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

Event Date 09/07/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 325957650
• Report Number: 1423507-2023-00104
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10885403146060
• UDI-Public: 10885403146060
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 32-2816
• Device Lot Number: K22XKA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1