MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000160
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the distal tip of a screwdriver broke off when torquing down on a screw during surgery.The broken distal portion of the driver was recovered without incident and there were no known patient complications.The screw was successfully tightened with an alternate driver.The complainant planned to return the broken driver, however, the instrument had inadvertently been discarded by a surgical tech at the hospital.The complainant stated that he was not entirely surprised by the instrument's malfunction, as the screwdriver had been in the tray for several years.A dhr review could not be performed because the lot number of the driver was not able to be provided to the manufacturer.
Event or Problem Description
The complainant reported that the distal tip of a screwdriver broke off when torquing down on a screw during surgery.There were no known patient complications.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7513063
• Report Number: 3005031160-2018-00011
• Device Sequence Number: 1422416
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170224
• 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): 05/14/2018

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: N60000160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/14/2018
• 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