MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER PIN CUTTER; CUTTER, WIRE

Model Number OS3035-003

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 11/28/2019

Event Type  malfunction  

Event Description

Attempted to cut the pin on the x-fix and the pin cutter broke in two places.The two shards flew through the air, and one hit the patient's leg leaving a minor laceration, and the other shard hit an employee leaving no injury.

• Brand Name: V. MUELLER PIN CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9503074
• MDR Text Key: 172222742
• Report Number: 9503074
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2019

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: OS3035-003
• Device Catalogue Number: OS3035-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Device Age: 1 YR
• Date Report to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16790 DA