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

Catalog Number	48394005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; central sterile services of the clinic, reported that "the distractor could not open completely, the handle broke inside by unscrewing it during a medical procedure.".
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was inspected and it was confirmed the side handle was fractured off the device.No relevant manufacturing issues were found upon manufacturing history review.The probable root cause of this event is user error.
Event or Problem Description
It was reported that; central sterile services of the clinic, reported that "the distractor could not open completely, the handle broke inside by unscrewing it during a medical procedure.".

• 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: 6384168
• Report Number: 0009617544-2017-00068
• Device Sequence Number: 19083257
• 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: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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 Catalogue Number: 48394005
• Device Lot Number: 160724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1