MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER CORE SUMEX DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL

Lot Number 1109600083

Device Problems Difficult to Remove (1528); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Event Description

Patient in surgery for lumbar laminectomy.Surgeon using a stryker core sumex drill.The drill became warm in surgeon's hand.The drill would then only work in reverse and the staff were unable to remove the drill bit from the drill.The drill was taken out of service and exchanged for a new drill.Problem was reported to the clinical leaders of the operating room and the manager of central sterile.The item was sent to central sterile to be returned to the manufacturer.No harm to the patient.

• Brand Name: STRYKER CORE SUMEX DRILL
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 7717844
• MDR Text Key: 115080961
• Report Number: MW5078575
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1109600083
• 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
• Patient Age: 44 YR
• Patient Weight: 100