MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM; INTERSPINOUS PROCESS FIXATION SYSTEM

Model Number	X060-0370
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the compressor was damaged while performing implant compression during surgery.There were no reported patient complications.A visual assessment of the compressor showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal end of the compressor right handle (sub-assembly component) was broken at the pivot point that connects the right and left handle of the instrument.The left and right handles of the instrument were not in alignment with one another.There were deep rotational scratches on the recessed portion of both handles surrounding the compressor center pin, which suggests that the clearance between the handles was too tight or that the handles were not in alignment with one another.A functionality assessment could not be performed, due to the damage.A dhr review was performed the instrument met all required specifications prior to being released to distributable inventory on 11/21/2011.A compressor could be damaged if the two handles of the instrument were twisted out of alignment, or by application of excessive force when compressing implants.If the handles of the instrument are twisted out of alignment, it may create friction and resistance that compromises the material integrity of the handles and could contribute to the handle breaking.Axle implants are compressed against the spinous process, driving the spikes of the implant into the patient bone.If the implants are compressed against the spinous process more than required for the spikes to fully engage patient bone, it may transfer applied force to the pivot point of the compressor.The location of the center pin is in an area where both left and right handles of the instrument have minimal material with stress risers present.Application of excessive compressing force to the instrument may result in one of the handles breaking.
Event or Problem Description
The complainant reported that the compressor was damaged while performing implant compression during surgery.There were no reported patient complications.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: INTERSPINOUS PROCESS FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8597833
• Report Number: 3005031160-2019-00026
• Device Sequence Number: 2011165
• Product Code: KWP
• UDI-Device Identifier: M697X06003701
• UDI-Public: M697X06003701
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K101471
• 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
• Report Date (Section B): 05/09/2019

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 Model Number: X060-0370
• Device Lot Number: 1140-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/09/2019
• 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