MAUDE Adverse Event Report: STRYKER INSTRUMENTS CAST; SAW, POWERED, AND ACCESSORIES

Model Number 940

Device Problems Break (1069); Fire (1245); Smoking (1585)

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

Event Date 11/12/2020

Event Type  No Answer Provided  

Event Description

Operating room procedure was in process when the cast saw was plugged into the wall power outlet, which energized an onboard power unit that provides power to the cast saw from the vacuum portion at the base of the unit.A pair of cast spreader pliers that were tethered to the unit by a vinyl coated cable made contact with a prong on the cast saw creating a dead short.The tether cable heated and burned causing the tether to sever, dropping the pliers and opening the short.A small flame and smoke was seen which self extinguished immediately.Fda safety report id# (b)(4).

• Brand Name: CAST
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 11348664
• MDR Text Key: 232562551
• Report Number: MW5099496
• Device Sequence Number: 1
• Product Code: HAB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CAST VACUUM - STRYKER MEDICAL MODEL #986 SERIAL # (B)(4)
• Patient Age: 11 YR
• Patient Weight: 36