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

Catalog Number 482319550

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/29/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6524684
• MDR Text Key: 73903349
• Report Number: 3005525032-2017-00052
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540598691
• UDI-Public: (01)04546540598691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No
• 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