MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM ROD ROTATION KEY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48237056
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the closed hex end broke during the case.
Additional Manufacturer Narrative
Visual inspection, material analysis, device history review, complaint history review, risk assessment; the reported event was confirmed upon visual inspection of the returned device.Mar was performed and it was found that rod rotational key fractured in mixed ductile and cleavage mode originating in the corner of the inner hex.No material or manufacturing defects were found.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The plausible cause of the reported event is user applying excessive torque and normal wear and tear of the device.
Event or Problem Description
It was reported that the closed hex end broke during the case.

• Brand Name: XIA 3 TITANIUM ROD ROTATION KEY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6205986
• Report Number: 0009617544-2016-00506
• Device Sequence Number: 1111095
• Product Code: LXH
• UDI-Device Identifier: 07613327265545
• UDI-Public: (01)07613327265545
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 48237056
• Device Lot Number: 149034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1