MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482616545
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the field representative.The screw was discarded at the hospital and is unavailable for evaluation.Manufacturing record review and complaint history review could not be performed as the lot number is unknown.It was reported that the patient's bone quality was average, no x-rays are available, the gauthier torque wrench was used with the xia 3 anti-torque tube and tightened to 12nm.The screw hole was prepared with a probe and 5.5 mm tap.The rod was fully reduced.It was reported that the surgeon does not apply excessive force but did have trouble seating the xia 3 anti-torque tube onto the screw.The surgeon reportedly "buries the screws into the bone." as the device was not returned, a definite root cause cannot be determined.Possible root causes include burying the screw head into the bone, as this impedes the polyaxialty of the screw causing more stress to be onto the bone and/or the screw which may, in turn, cause the bone or the screw to break if enough force is applied.Additionally, the surgeon's struggles with the anti-torque tube may have contributed as this may have caused off-cantilever force to be applied to the screw during final tightening, which may have caused the bone to fracture.Device discarded.
Event or Problem Description
A physician reported that a serrato polyaxial screw, "broke out of pedicle when final tightening." the surgery was completed successfully following a 30-minute delay in which the construct was extended by one level to accommodate skipping the level with the broken pedicle.

• Brand Name: 6.5X45 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10610072
• Report Number: 3005525032-2020-00040
• Device Sequence Number: 18925698
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• 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
• Report Date (Section B): 09/30/2020

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 Model Number: 482616545
• Device Catalogue Number: 482616545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1