MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATED SERRATO TAP 5.0MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	48260250
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an l4/5 plif, upon insertion of pedicle screw into l4 vertebral body, the pedicle root broke.It was also reported that the pedicle was deformed due to degenerative scoliosis.There was no reported issue with the device.
Additional Manufacturer Narrative
Corrected data: catalog number was corrected.Method: labeling review, risk assessment.The device was not returned, and a lot number was not provided, therefore no further inspection/evaluation of the device could be performed.According to the surgical technique guide, "for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body.With the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended." the most likely root cause is under-tapping of the screw hole, causing excess torque that fractured the pedicle.The patient's preexisting condition may have also contributed to the event.As the device was not returned, a definitive root cause could not be determined.Device not returned.
Event or Problem Description
It was reported that during an l4/5 plif, upon insertion of pedicle screw into l4 vertebral body, the pedicle root broke.It was also reported that the pedicle was deformed due to degenerative scoliosis.There was no reported issue with the device.

• Brand Name: NAVIGATED SERRATO TAP 5.0MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7879027
• Report Number: 0009617544-2018-00222
• Device Sequence Number: 1758081
• Product Code: OLO
• UDI-Device Identifier: 07613327353051
• UDI-Public: 07613327353051
• Combination Product (Y/N): N
• 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): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 48260250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1