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

Catalog Number	4826195100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8114493
• Report Number: 3005525032-2018-00078
• Device Sequence Number: 1692075
• Product Code: NKB
• UDI-Device Identifier: 07613327351750
• UDI-Public: 07613327351750
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1