MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317550
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw had bad threading inside tulip of 7.5mm x 50mm screw.Update (b)(6) 2016): the threading would not allow the polyaxial screwdriver to thread into the tulip.Another screw was tried, and was successful.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the returned screw was threaded on the end of a test xia 3 polyaxial screwdriver with no issues.A test blocker was then threaded into the tulip head.No issues were found during testing.The screwdriver and blocker were both able to be threaded and unthreaded with no issues.The device worked as expected.It is possible the user did not have the screw seated on the screwdriver properly causing it to not thread correctly.Conclusion: the most likely cause of the event is user error.
Event or Problem Description
It was reported that; screw had bad threading inside tulip of 7.5mm x 50mm screw.Update (1-may-2016): the threading would not allow the polyaxial screwdriver to thread into the tulip.Another screw was tried, and was successful.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5691236
• Report Number: 3005525032-2016-00061
• Device Sequence Number: 10858952
• Product Code: MNH
• UDI-Device Identifier: 04546540562364
• UDI-Public: (01)04546540562364
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• 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): 05/09/2016

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: 482317550
• Device Lot Number: B03610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR