MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number	48233540
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was undertaking a spinal procedure and after everything had been locked down the surgeon felt that the construct was loose.He felt around to understand what was happening and as he did so the tulip head came off the screw in the surgeon's hand.The surgeon was able to remove the shaft of the screw and insert a new one.The case was completed successfully and there were no adverse consequences for the patient.There was a couple of minutes delay while the new screw was inserted.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported was confirmed via visual inspection.The tulip head was disengaged from the main thread body.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: due to the multifactorial nature of the event, a definite root cause cannot be determined.
Event or Problem Description
It was reported that the surgeon was undertaking a spinal procedure and after everything had been locked down the surgeon felt that the construct was loose.He felt around to understand what was happening and as he did so the tulip head came off the screw in the surgeon's hand.The surgeon was able to remove the shaft of the screw and insert a new one.The case was completed successfully and there were no adverse consequences for the patient.There was a couple of minutes delay while the new screw was inserted.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 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: 6582643
• Report Number: 0009617544-2017-00210
• Device Sequence Number: 324810
• Product Code: NKB
• UDI-Device Identifier: 07613327001037
• UDI-Public: (01)07613327001037
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 08/03/2017

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: 48233540
• Device Catalogue Number: 48233540
• Device Lot Number: 170362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1