MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X100 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 4826195100

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  malfunction  

Event Description

It was reported that the screw broke during surgery, a part of screw was left in the patient.A surgical delay of 10 minute was reported.No adverse consequences to the patient has been reported.

Manufacturer Narrative

Method: visual inspection, material analysis, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via visual inspection of the returned product.The tulip and its locking ring showed no signs of damage.Material analysis found that the device was found to have fractured in a mode of ductile overload due to an applied torsional force.The elemental constituents met the print requirements.It was reported that the patient had hard bone, which would contribute to the difficulty inserting the screw that would require more force than usual and cause the ductile overload due to an applied torsional force.Conclusion: the root cause of the reported event is excessive force applied with screw hole preparation, under tapping, and patient bone quality being contributing factors.

Event Description

It was reported that the screw broke during surgery, a part of screw was left in the patient.A surgical delay of 10 minute was reported.No adverse consequences to the patient has been reported.

• Brand Name: 9.5X100 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8114493
• MDR Text Key: 128746533
• Report Number: 3005525032-2018-00078
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351750
• UDI-Public: 07613327351750
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 4826195100
• Device Lot Number: B72295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1