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

Model Number	48394005
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; this device was used at an extreme angle under exceeding pressure.Update 8/2/2017: the tip broke.
Additional Manufacturer Narrative
The customer reported event was confirmed via functional inspection.The internal mechanism of the device was found broken.Manufacturing history was reviewed and no issues were identified.A root cause of the event was determined to be patients' tight disk space as well as using the device at extreme angle.
Event or Problem Description
It was reported that; this device was used at an extreme angle under exceeding pressure.Update 8/2/2017: the tip broke.

• 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: 6825873
• Report Number: 0009617544-2017-00338
• Device Sequence Number: 648542
• Product Code: LXH
• UDI-Device Identifier: 07613327270648
• UDI-Public: (01)07613327270648
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/08/2017

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
• 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: 08/16/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1