MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM; PLIERS ALL-IN-ONE INSERTER/COMPRESSOR, ASSEMBLY

Model Number	X060-1520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that an axle all in one inserter broke during insertion of an implant.A second inserter was available, and the procedure was completed.There were no known patient complications.Visual assessment of the instrument identified that a subassembly part was sheared off which would prevent the inserter from functioning as intended.The fracture appeared to start on the inside corner of the tip where there is a sharp corner and potential stress riser.A dhr review was performed, and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.
Event or Problem Description
The complainant reported that an axle all in one inserter broke during insertion of an implant.A second inserter was available, and the procedure was completed.There were no known patient complications.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: PLIERS ALL-IN-ONE INSERTER/COMPRESSOR, ASSEMBLY
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8010522
• Report Number: 3005031160-2018-00031
• Device Sequence Number: 1484177
• Product Code: HTC
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: Health Professional
• Device Model Number: X060-1520
• Device Lot Number: 584601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/26/2018
• 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