MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 7.5X35MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482804735
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery the surgeon tightened the blocker using the torque wrench.When the surgeon pulled out the torque wrench, the screw head separated.Therefore the surgeon changed the screw to another same size screw.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assesment.The device was inspected and it was found to be returned in two pieces.The tulip head was disengaged from the main screw body.Upon manufacturing history review, no relevant manufacturing issues were identified as all units met stryker specifications.According to the referenced risk file, an incorrect alignment of blocker to tulip head may lead to tulip separation.Visual inspection of the returned product confirms that the blocker was jammed into the tulip head, likely due to an improper alignment.Excessive force may have been applied to the blocker causing the inner hex shape to deform and the tulip head to separate from the screw.The plausible root cause of this event is determined to be user error - incorrect alignment of the blocker.
Event or Problem Description
It was reported that; during surgery the surgeon tightened the blocker using the torque wrench.When the surgeon pulled out the torque wrench, the screw head separated.Therefore the surgeon changed the screw to another same size screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X35MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5894735
• Report Number: 0009617544-2016-00342
• Device Sequence Number: 915983
• Product Code: NKB
• UDI-Device Identifier: 07613327002218
• UDI-Public: (01)07613327002218
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• 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): 07/27/2016

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: 482804735
• Device Lot Number: 13C453
• 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: 07/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1