MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 50MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482319550
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; dr.Placed 9.5x50 screw in left s1 pedicle during revision surgery.Dr was replacing current 8.5 diameter screw with larger due to having a 'loose feel'.Upon placement, dr wanted to removed and redirect due to 'poor' trajectory, but could not.Dr.Broke handle/driver/nut trying to remove with primary driver, then switch to lumbar removal driver over a locked down piece of rod with blocker to top of tulip to try to 'helicopter' screw out since it was so stuck.During process of trying to remove, he broke tulip/ head off of screw off of main screw shaft.Dr could not remove remainder of broken screw from patient with lumbar removal set - so he left it in place due to not having effect pm patient's outcome and moved on with case.
Additional Manufacturer Narrative
Risk assessment; visual, dimensional and functional analysis could not be performed as the device was not returned and no lot# was provided.The most likely root cause is excessive force was applied to the screw causing it to disengage, with incorrect trajectory of the screw also contributing to the event.
Event or Problem Description
It was reported that; dr.Placed 9.5x50 screw in left s1 pedicle during revision surgery.Dr was replacing current 8.5 diameter screw with larger due to having a 'loose feel'.Upon placement, dr wanted to removed and redirect due to 'poor' trajectory, but could not.Dr.Broke handle/driver/nut trying to remove with primary driver, then switch to lumbar removal driver over a locked down piece of rod with blocker to top of tulip to try to 'helicopter' screw out since it was so stuck.During process of trying to remove, he broketulip/ head off of screw off of main screw shaft.Dr could not remove remainder of broken screw from patient with lumbar removal set - so he left it in place due to not having effect pm patient's outcome and moved on with case.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 50MM
• 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: 6524684
• Report Number: 3005525032-2017-00052
• Device Sequence Number: 18835740
• Product Code: MNI
• UDI-Device Identifier: 04546540598691
• UDI-Public: (01)04546540598691
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• 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): 06/22/2017

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: 482319550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1