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

Model Number	03756230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7221018
• Report Number: 3005525032-2018-00005
• Device Sequence Number: 16440504
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K982494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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 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
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR