MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. X-SPINE PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	N60000485
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complainant communicated on (b)(6) 2019 that an instrument broke during a surgical procedure on (b)(6) 2019.The complainant provided photos of the broken compressor, which showed an instrument with repeated use as identified by worn laser markings, surface scratches, and a failed weld at the pivot point of the instrument.A functionality assessment could not be performed due to not receiving the instrument for complaint assessment.A dhr review was performed for lot# f3025 and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 07/22/2011.The complainant reported that the compressor split during surgery, although the surgeon was able to successfully complete the procedure with the same instrument, though it was reported to be very unstable.The distal prongs of the compressor would not maintain a secure connection with system screws and rods when the instrument handles were compressed if the instrument assembly components were not adequately connected.Photos of the complaint instrument were provided, which showed a failed weld at the pivot point of the instrument that allowed the instrument assembly components to be separated.It cannot be reliably determined why the weld at the pivot point failed.It could be possible that application of excessive force may have contributed to the instrument malfunction.If excessive force was applied to the compressor while it was between the two different functional positions, it could transfer applied force to the pivot weld and may fail as observed.
Event or Problem Description
The complainant reported that a compressor instrument split during a surgical procedure on (b)(6) 2019.There were no reported patient complications.
Additional Manufacturer Narrative
This is a follow up report to 3005031160-2020-00001.The complainant returned the broken compressor to the company on 02/06/2020.A visual assessment of the instrument showed an device with repeated use as identified by worn laser markings, surface scratches, and a failed weld at the pivot point of the instrument.A functionality assessment could not be performed due to the condition of the complaint instrument.

• Brand Name: X-SPINE PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9603269
• Report Number: 3005031160-2020-00001
• Device Sequence Number: 1965568
• Product Code: MNI
• UDI-Device Identifier: M697N600004851
• UDI-Public: M697N600004851
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: N60000485
• Device Lot Number: F3025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other