MAUDE Adverse Event Report: STRYKER SPINE-US REDUCTION POLYAXIAL SCREW 6.5X40; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482626540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion of the rod into the screws, the head of the screws broke.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the representative.All broken fragments were retrieved, however, the devices are unavailable for evaluation as they were implanted.Lot numbers were not provided, so manufacturing records review could not be completed.It was reported that the surgeon used an inappropriate instrument.For inserting screws, the serrato surgical technique states to use the serrato screwdriver with serrato screws.The screwdriver reportedly used is not listed in the surgical technique as a screwdriver to be used with serrato screws.The xia ii screwdriver has a different tip that mates with the xia ii screw interface, which uses a 4 point design as opposed to a 6 point design.This instrument is not compatible with the serrato system.In addition, the surgeon appeared to apply excessive force as they used an instrument of the other technique, and it wasn't aligned and the angle was inappropriate.Conclusion: the most likely root cause is user error as an incompatible screwdriver was used.
Event or Problem Description
It was reported that during insertion of the rod into the screws, the head of the screws broke.No adverse consequences to the patient were reported.

• Brand Name: REDUCTION POLYAXIAL SCREW 6.5X40
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7686488
• Report Number: 0009617544-2018-00171
• Device Sequence Number: 904263
• Product Code: NKB
• UDI-Device Identifier: 07613327351910
• UDI-Public: 07613327351910
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: No Information
• Device Catalogue Number: 482626540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1