MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0425
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 contacted the company to report a possible complaint with a certex cross connector locking driver (part # x067-0425).The complainant reported that the tip of the driver cracked off and stayed lodged in the set screw.The individual reporting the complaint was present during the surgery, however, was unable to see the damage and was unable to confirm if a portion of the locking driver remained in the set screw.There were no known complications or harm done to the patient.The instrument was returned for complaint assessment on 03/22/2018.A visual inspection of the driver confirmed that the distal tip is broken and not present.The visual inspection also identified signs of frequent use.A functionality test could not be performed due to the extensive damage present.The dhr for the device lot was reviewed, and there wer no manufacturing anamolies identified.The device met the required specifications prior to being released for distribution.The instrument has been available for distribution since 08/28/2013.The complainant was contacted to confirm if a torque driver handle and cross connector counter torque sleeve were being used at the time of the breakage.The complainant stated that the aforementioned accessory devices were not being used.The associated surgical technique guide states that the use of the tools provided limit the amount of torque at the distal tip of the driver to prevent damage to the tools and implants.
Event or Problem Description
The complainant contacted the company to report a possible complaint with a certex cross connector locking driver (part # x067-0425).The complainant reported that the tip of the driver cracked off and stayed lodged in the set screw.The individual reporting the complaint was present during the surgery, however, was unable to see the damage and was unable to confirm if a portion of the locking driver remained in the set screw.There were no known complications or harm done to the patient.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7444615
• Report Number: 3005031160-2018-00008
• Device Sequence Number: 1216335
• Product Code: HXX
• UDI-Device Identifier: M697X06704251
• UDI-Public: M697X06704251
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160428
• 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): 04/18/2018

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: X067-0425
• Device Lot Number: 043503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/19/2018
• 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