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

Model Number	48394005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; handle broke off of instrument and part of it is stuck in thread.
Additional Manufacturer Narrative
No relevant manufacturing issues were found upon manufacturing history review.Material analysis was performed for a similar event.The observed elemental composition and measured hardness were as required per the drawing and heat treatment specification.No material or manufacturing defects were found.Upon follow up correspondence, it was reported the handle came off while removing the instrument from the patient's body.The instrument was already away from the patient cavity.No delay reported and no adverse consequences reported.Some of the possible root causes of the reported event are lack of lubrication leading to device jamming and requiring excessive force, or excessive force applied during distraction.The exact root cause of this event could not be determined conclusively.
Event or Problem Description
It was reported that; handle broke off of instrument and part of it is stuck in thread.

• Brand Name: NAVIGATOR DISC SPACE DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7150884
• Report Number: 0009617544-2017-00447
• Device Sequence Number: 1066373
• Product Code: LXH
• UDI-Device Identifier: 07613327270648
• UDI-Public: (01)07613327270648
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: No Information
• Device Model Number: 48394005
• Device Catalogue Number: 48394005
• Device Lot Number: 160724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1