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

Model Number	N60000160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that one screwdriver's distal tip fractured during surgery.There were no reported patient complications.A visual assessment of the returned driver showed an instrument with repeated use, as identified by surface scratches, worn laser markings, and surface staining.The misshaped tip indicated a screw was being driven (clockwise rotation) when the distal tip was broken.There was a scratch through the tin coating observed on the retention arm.The enlarged tip of the retention arm was fractured and not present.It was confirmed that the broken distal portion of the driver was recovered however, it was discarded at the facility after the procedure was finished.The device met all required specifications prior to being released to distributable inventory on 05/03/2012.The tip of a screwdriver could break if there were excessive force applied to the instrument or if the patient had unusually dense bone.Dense patient bone creates increased resistance to the instruments being used in the procedure, which may contribute to the distal tip of the screwdriver breaking.In step 6-drilling of the surgical technique guide, it states that "the system is designed to be used with the self-drilling screws provided.Self-drilling screws preserve cancellous bone for screw purchase and generally result in improved screw fixation compared with drilled screws.In cases where there is unusually hard bone present, drilling can be performed." it may be possible that the drilling and tapping steps that may be appropriate for patients with dense bone, were not performed in an effort to preserve cancellous bone for screw purchase.
Event or Problem Description
The complainant reported that one screwdriver's distal tip fractured during surgery.There were no reported patient complications.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8597707
• Report Number: 3005031160-2019-00027
• Device Sequence Number: 11310559
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052292
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: N60000160
• Device Lot Number: I5962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• 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