MAUDE Adverse Event Report: STRYKER SPINE-US BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48850000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final tightening, the surgeon noticed that the torque wrench kept popping out of the blocker.Upon further examination, the surgeon noticed that the blocker had cracked.A surgical delay of 45 seconds was reported.The surgery was completed replacing cracked blocker with a new one.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
The complaint device was returned.Lot number added.A supplemental mdr will be filed upon completion of the investigation.
Event or Problem Description
It was reported that during final tightening, the surgeon noticed that the torque wrench kept popping out of the blocker.Upon further examination, the surgeon noticed that the blocker had cracked.A surgical delay of 45 seconds was reported.The surgery was completed replacing cracked blocker with a new one.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Visual inspection confirmed returned blocker was fractured as reported, threads and opening of the blocker are deformed, the bottom of the blocker, right side, has a deep rod indentation, and the indentations are very light on the left side.Functional inspection could not be performed as the blocker is fractured.Dimensional inspection could not be performed because there is no indication the event was related to dimensions of the device.Material analysis confirmed blocker was found to have fractured in the top two threads in a mode of ductile overload.Upon examination of the inner hex, witness marks from the torque wrench were observed where the torque wrench was not fully seated in the hex, which likely caused the blocker to fracture.The observed elemental constituent was consistent with the drawing requirements.No material or manufacturing defects were found.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.The blocker was returned for evaluation and the reported event was confirmed.The blocker was fractured and the threads as well as opening of the blocker were deformed.It was reported that the blocker did not appear to be misaligned or cross threaded, no visible damage to the torque wrench nor to the blocker was noticed prior to the surgery, no excessive or cantilever force applied, the blocker was fully inserted onto the inserter, arrows on the torque were aligned, anti torque key was used, and the surgeon did not appear to apply excess torque during initial blocker insertion.The plausible root cause of the reported event is fracture due to ductile overload and not fully seating the blocker in the torque wrench.
Event or Problem Description
It was reported that during final tightening, the surgeon noticed that the torque wrench kept popping out of the blocker.Upon further examination, the surgeon noticed that the blocker had cracked.A surgical delay of 45 seconds was reported.The surgery was completed replacing cracked blocker with a new one.No other adverse consequence to the patient was reported.

• Brand Name: BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8493333
• Report Number: 0009617544-2019-00041
• Device Sequence Number: 1254129
• Product Code: NKB
• UDI-Device Identifier: 07613327132526
• UDI-Public: 07613327132526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2019

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: Health Professional
• Device Catalogue Number: 48850000
• Device Lot Number: 26H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 06/14/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 04/29/2019; 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1