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

Catalog Number	48850000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-scheduled fusion extension surgery, the surgeon noted the blockers were already loose.No adverse consequences to the patient.The surgery was completed successfully.
Additional Manufacturer Narrative
Product identification confirmed the return of 4 blockers; this record is the description of blocker number 2.Visual inspection confirmed the blocker had very light rod indentations which is an indication that the blocker was under-tightened.Dimensional inspection was not performed because there is no indication the event was related to dimensions of the device.Material analysis was not performed as there is no indication the event was related to the material properties of the device.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.Complaint history was reviewed for the lot provided and one similar complaint was identified.The event resulted in 3-4 minute surgical delay.There were no broken fragment.No complications during the initial surgery.Bone quality of the patient was good, patient did not experience a fall, x-rays, and patient information are not available.The likely root cause of the event is the inconsistency of the blocker tightening and instability of the construct.These factors combined can cause the blocker to loosen.Additionally, the device was implanted for approximately 3 years; length of the implantation may have contributed to the event.In addition, contributing factors to blocker under/over-tightening: surgeon "white knuckles" the torque wrench.Surgeon unable to read the laser marking.Blocker cross threads with the screw.Torque wrench is not able to provide enough torque.Per the surgical technique: ¿once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.To final tighten; use the anti-torque key and the torque wrench.Step 3: line up the two arrows to achieve the final tightening torque of 8nm.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Note: do not exceed 8nm during final tightening.The anti-torque key must be used for final tightening.¿ from the ifu: ¿while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.¿.
Event or Problem Description
It was reported that during a pre-scheduled fusion extension surgery, the surgeon noted the blockers were already loose.No adverse consequences to the patient.The surgery was completed successfully.

• 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: 8573242
• Report Number: 0009617544-2019-00067
• Device Sequence Number: 1587334
• 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
• Report Date (Section B): 07/09/2019

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: N73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1