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

Model Number 48233540

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6582643
• MDR Text Key: 75881948
• Report Number: 0009617544-2017-00210
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327001037
• UDI-Public: (01)07613327001037
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: 04/26/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1