MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 45-60 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48133245
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during small surgery, the surgeon used the cross connector.And the surgeon used the set screw driver.However, it wasn't possible to tighten the set screw.When the surgeon checked the cross connector, the set screw was broken.Therefore, the surgeon changed the cross connector to another same size product.
Additional Manufacturer Narrative
Lot# 14h278.Visual inspection; device history review; complaint history review; risk assessment; no relevant manufacturing issues were identified as all units met stryker specifications.The returned connector was confirmed to have a jammed set screw, which was fully backed out.It is likely that the set screw was fully backed out past the acceptable range, which resulted in the set screw being jammed.The most likely cause of the customer reported event is over-torqueing of the set screw while backing it out.
Event or Problem Description
It was reported that; during small surgery, the surgeon used the cross connector.And the surgeon used the set screw driver.However, it wasn't possible to tighten the set screw.When the surgeon checked the cross connector, the set screw was broken.Therefore the surgeon changed the cross connector to another same size product.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 45-60 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: 5865213
• Report Number: 0009617544-2016-00330
• Device Sequence Number: 13602995
• Product Code: MNH
• UDI-Device Identifier: 04546540515100
• UDI-Public: (01)04546540515100
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• 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): 07/13/2016

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: 48133245
• Device Lot Number: 14H278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1