MAUDE Adverse Event Report: STRYKER/ HOWMEDICA OSTEOMICS STRYKER TROCAR; ACCESSORIES ARTHROSCOPIC

Model Number B12LT

Device Problem Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

Smudges scratches on trocar.

• Brand Name: STRYKER TROCAR
• Type of Device: ACCESSORIES ARTHROSCOPIC
• Manufacturer (Section D): STRYKER/ HOWMEDICA OSTEOMICS; tempe AZ 85283
• MDR Report Key: 6830525
• MDR Text Key: 84429256
• Report Number: MW5071838
• Device Sequence Number: 1
• Product Code: NBH
• 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: 08/28/2017

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 Expiration Date: 03/28/2020
• Device Model Number: B12LT
• Device Lot Number: 6088506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR