MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	48236043
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; after final fixation, when the multiaxial crosslink was deployed and the center nut was loosed, the inner screw was broken.Therefore, the multiaxial crosslink was changed the new same one and the operation was succeeded.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The tightening nut end cap was found to be fractured in 2 pieces indicating overtightening, which in turn, caused the rest of the device to disengage into several pieces.No relevant manufacturing issues were identified as all units met stryker specifications.The plausible root cause of the event is determined to be over torqeuing of the set screw leading to fracture.
Event or Problem Description
It was reported that; after final fixation, when the multiaxial crosslink was deployed and the center nut was loosed, the inner screw was broken.Therefore, the multiaxial crosslink was changed the new same one and the operation was succeeded.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6681469
• Report Number: 0009617544-2017-00272
• Device Sequence Number: 16183578
• Product Code: MNI
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• 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): 09/20/2017

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: 48236043
• Device Catalogue Number: 48236043
• Device Lot Number: 167627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR