MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM BLOCKER; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number 48230000

Device Problems Crack (1135); Difficult to Remove (1528)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/16/2016

Event Type  Injury  

Event Description

It was reported that; we did a 1 level posterior lumbar fusion on thursday (b)(6) 2016.When final tightening the construct with the breakaway torque wrench, the blocker cracked.We couldn't remove, at the time physician felt the blocker was tight enough to hold the rod.Patient presented with leg pain on opposite side of broken blocker.Physician brought patient back to revise all 4 screws.We had to cut the rod and helicopter the screw out.All 4 screws were revised and direction of screws were changed , final tightened.

Manufacturer Narrative

Lot# c9v.Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection showed the blocker was almost flush with the top of the tulip head and some deformity was noticed on the bottom of the blocker where it touches the rod indicating excessive torque applied during final tightening.The surgical technique states "optimal force should be applied during final tightening.Do not exceed 12nm during final tightening." conclusion: the most likely cause of the reported event was determined to be deviation from surgical technique by using excessive torque for final tightening as a result of using a non-stryker torque wrench.

Event Description

It was reported that; we did a 1 level posterior lumbar fusion on (b)(6) 2016.When final tightening the construct with the breakaway torque wrench, the blocker cracked.We couldn't remove, at the time physician felt the blocker was tight enough to hold the rod.Patient presented with leg pain on opposite side of broken blocker.Physician brought patient back to revise all 4 screws.We had to cut the rod and helicopter the screw out.All 4 screws were revised and direction of screws were changed , final tightened.

• Brand Name: XIA 3 TITANIUM BLOCKER
• 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: 5707560
• MDR Text Key: 46856620
• Report Number: 3005525032-2016-00065
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540560193
• UDI-Public: (01)04546540560193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48230000
• Device Lot Number: C9V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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
• Patient Outcome(s): Required Intervention