MAUDE Adverse Event Report: STRYKER SPINE-US XIA BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number 03756230

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)

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

Event Date 12/13/2017

Event Type  malfunction  

Event Description

I was reported that when doctor used 2 polyaxial screws and 2 reduction long arm monoaxial screws.He inserted the screw on the left of s1.When he tried to use the cap inserter instrument to lock the cap into the screw, he found the cap is broken.There is a broken line on the cap.The doctor tried to get the broken cap.Out.However, because of the broken line, the cap was bigger than the head of the cap inserter, it was hard to get the cap out.Finally, after about 40 min,he used the cutter to cut the cap into pieces and got the pieces out, reinserted a new cap.

Manufacturer Narrative

The blocker fractured during locking down the blocker.The universal tightener was used, which is just to be used for blocker insertion.For final tightening, the torque wrench must be used to ensure that excess torque is not applied to the blocker.The most likely root cause is excess force was applied to the blocker during tightening with either the driver not fully seated into the blocker or a deformed driver was used, causing the blocker to deform and eventually fracture.

Event Description

I was reported that when doctor used 2 polyaxial screws and 2 reduction long arm monoaxial screws.He inserted the screw on the left of s1.When he tried to use the cap inserter instrument to lock the cap into the screw, he found the cap is broken.There is a broken line on the cap.The doctor tried to get the broken cap.Out.However, because of the broken line, the cap was bigger than the head of the cap inserter, it was hard to get the cap out.Finally, after about 40min, he used the cutter to cut the cap into pieces and got the pieces out, reinserted a new cap.

• Brand Name: XIA BLOCKER
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7221018
• MDR Text Key: 98646201
• Report Number: 3005525032-2018-00005
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K982494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 03756230
• Device Catalogue Number: 03756230
• Device Lot Number: C4T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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 Age: 56 YR