MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802740
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product history review, complaint history review, labeling review, risk assessment the reported event was confirmed via email correspondence with the sales rep.The product was not returned.Three different lot#s were provided.It is unknown which one of these had its blade fractured.Device history review was performed on all the 3 lot#s.No relevant manufacturing issues were found for any of the 3 lot numbers.The doctor tried to change the angle of the screw, while the blade broke.The issue did not occur during insertion of blocker or during final tightening of blocker.The angle was too steep where the surgery was being performed.The blocker was properly assembled to inserter.It is unknown if the blocker was cross threaded with screw tulip head threading.It is likely that the screw tab may have fractured due to too much stress applied on the construct while inserting the blockers.However, the exact root cause could not be determined conclusively.Device not returned.
Event or Problem Description
It was reported that the blade fractured during a surgery.No adverse consequences to the patient is reported.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 8035186
• Report Number: 0009617544-2018-00258
• Device Sequence Number: 1463585
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: 07613327002003
• 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
• Report Date (Section B): 11/02/2018

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: Health Professional
• Device Catalogue Number: 482802740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR