MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482802645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous arthrodesis, insertion of 4 screws into the pedicles of the patient.Then, to proceed the discectomy to insert a rotative lumbar cage into the intradiscal space, the surgeon installed the pbr spacer.He introduced a short pin into each supporting screws of the spacer.To insert the pin into the thread of the screw, the surgeon used a counter torque key to hold the screw.When inserting the pin into the thread, the short fins of the screw broke.They fractured at the level of the space provided to allow breaking at the end of the intervention.The surgeon replaced the screw by a new one.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was returned in 3 pieces.Both tabs were fractured off of the screw.No relevant manufacturing issues found upon device history review.The exact root cause could not be determined conclusively.
Event or Problem Description
It was reported that during a percutaneous arthrodesis, insertion of 4 screws into the pedicles of the patient.Then, to proceed the discectomy to insert a rotative lumbar cage into the intradiscal space, the surgeon installed the pbr spacer.He introduced a short pin into each supporting screws of the spacer.To insert the pin into the thread of the screw, the surgeon used a counter torque key to hold the screw.When inserting the pin into the thread, the short fins of the screw broke.They fractured at the level of the space provided to allow breaking at the end of the intervention.The surgeon replaced the screw by a new one.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6307068
• Report Number: 0009617544-2017-00054
• Device Sequence Number: 1007891
• Product Code: NKB
• UDI-Device Identifier: 07613327001945
• UDI-Public: (01)07613327001945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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 Catalogue Number: 482802645
• Device Lot Number: 167144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1