MAUDE Adverse Event Report: STRYKER CORPORATION LITE DECOMPRESSION DILATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/24/2020

Event Type  malfunction  

Event Description

Bioburden released from inside of dilator from lite decompression tube tray when 18mm tube was passed through dilator during posterior cervical minimally invasive partial laminectomy and foraminotomy at left c6-c7.Patient received 3gm ancef intraoperatively.Found particles on seals and dilators.Checked the parts for bio-burden.After cleaning the parts, swabbed inside and found brown/grey residue.Expanded testing to other devices and also determined stryker tubes had a similar residue inside.To test inside, used a sterile cotton swab and sterile water to scrub.Cotton tip looked brown/grey.Tested all tubes and dilators with a dry sterile swab, then a moist (sterile water) sterile swab, then a moist (70% alcohol) sterile swab.Each time, residue was found.Provided a new tube set from inventory.Swab test confirmed a residue in the new set.The new set has since been cleaned and is being used at the hospital.A high sense of urgency is needed by stryker to support this investigation.Stryker: we are committed to urgently support this investigation and get good parts to the hospital for usage.

• Brand Name: LITE DECOMPRESSION DILATOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10717756
• MDR Text Key: 212488612
• Report Number: 10717756
• Device Sequence Number: 1
• Product Code: LXH
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2020
• Date Report to Manufacturer: 10/22/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1