MAUDE Adverse Event Report: XTANT MEDICAL 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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company received notification on (b)(6) 2020 that a surgical instrument had a malfunction during a surgical procedure.It was reported that the distal end of a system inserter/compressor fractured when being used to compress implant plates.There were no known patient complications associated with this complaint.There was an alternate instrument available, which was used to successfully complete the procedure.A visual assessment of the returned inserter/compressor showed an instrument with repeated use, as identified by surface scratches, worn laser markings, and minor surface staining.The handle a tip was broken from the body of the instrument.The metal cylinder at the proximal end of the handle a tip was sheared off, leaving a portion of the fractured cylinder within the handle a main body.A functionality assessment could not be performed due to the broken condition of the instrument.A dhr review was performed for the complaint lot and the devices met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 12/19/18.It may be possible that application of excessive compression force may have contributed to the handle a tip fracturing from the instrument.The handle a tip is secured into the body of the instrument with a cylinder that has minor movement to allow for implant engagement.It may be possible that over compressing the instrument may concentrate applied force to the handle a tip, resulting in an instrument malfunction.
Event or Problem Description
The company received notification on (b)(6) 2020 that a surgical instrument had a malfunction during a surgical procedure.It was reported that the distal end of a system inserter/compressor fractured when being used to compress implant plates.There were no known patient complications associated with this complaint.There was an alternate instrument available, which was used to successfully complete the procedure.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLY
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade, mt
• MDR Report Key: 10289073
• Report Number: 3005031160-2020-00017
• Device Sequence Number: 11628673
• Product Code: HTC
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• 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,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X060-1520
• Device Lot Number: 10675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• 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
• Patient Age: 74 YR