MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR DISC SPACE DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48394005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distractor was returned to the central sterilization services broken after the surgery.Sterilization procedures were properly followed when setting up the consignment.A supplemental report will be provided upon completion of the investigation.
Event or Problem Description
The surgeon reported that a distractor failed suddenly during distraction, during a tlif mini invasive l4 l5 surgery.The surgeon reported hearing a "clack" and thought a piece broke inside the mechanism.The mechanism did not seize.The surgeon was able to retract the instrument to remove it from the patient.The procedure was completed successfully with no delay.There were no adverse health consequences to the patient.
Event or Problem Description
The surgeon reported that a distractor failed suddenly during distraction, during a tlif miniinvasive l4 l5 surgery.The surgeon reported hearing a "clack" and thought a piece broke inside the mechanism.The mechanism did not seize.The surgeon was able to retract the instrument to remove it from the patient.The procedure was completed successfully with no delay.There were no adverse health consequences to the patient.

• Brand Name: NAVIGATOR DISC SPACE DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7278677
• Report Number: 0009617544-2018-00044
• Device Sequence Number: 1316938
• Product Code: LXH
• UDI-Device Identifier: 07613327270648
• UDI-Public: (01)07613327270648
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: 48394005
• Device Catalogue Number: 48394005
• Device Lot Number: 125732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1