MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48133230
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgeon used a cross connector.The surgeon forced a driver tip into the screw of the cross connector using a driver, the screw of the cross connector broke.The surgeon changed the cross connector to another same size product.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the returned was confirmed to be jammed upon functional inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the most likely cause of the customer reported event is over-torquing of the set screw while backing it out.
Event or Problem Description
It was reported that during the surgery, the surgeon used a cross connector.The surgeon forced a driver tip into the screw of the cross connector using a driver, the screw of the cross connector broke.The surgeon changed the cross connector to another same size product.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5509219
• Report Number: 0009617544-2016-00118
• Device Sequence Number: 16403512
• Product Code: MNH
• UDI-Device Identifier: 04546540515087
• UDI-Public: (01)04546540515087
• Combination Product (Y/N): N
• PMA/510(K) Number: K060748
• 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): 02/22/2016

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: 48133230
• Device Lot Number: 14H268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2016
• Supplement Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR