MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number G7753500

Device Problems Break (1069); Material Deformation (2976)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

The following products have been used in the surgery: catalog#: g7753500, lot#: 0671677w.Qty-1 catalog#: g7753500, lot#: 0467684w.Qty-1 it is unknown which lot# of the product has stripped.Similar device catalog #: 7753500, 510k #: k082728, udi#: (b)(4) is marketed in the united states.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturer representative regarding patient with cervical dislocation fracture involved in reduction, posterior spinal fixation after decompression procedure used in spinal therapy.It was reported during procedure, upper part of set screw stripped during inserting mas crosslink set screw.Product came in contact with patient.The thread part could not be removed and fragment remained in the patient's body.It was reported that, mas crosslink set screw itself was tightened by using a torque.The mas crosslink set screw was not cross-threaded.The upper hexagonal part broke, when mas cross link set screw was finally tightened and fragments were left in the patient body.Also, reported gripper of screw driver was removed.There was delay in overall procedure time for 5 minutes.There is no patient symptoms or complications reported as a result of the event.The procedure was completed with new product.There is no revision surgery planned or scheduled.

Manufacturer Narrative

H3: device evaluated summary: model#-g7753500, lot#- 0467684w, visual inspection confirmed the mas connector is broken at the base of the connector hex head.The bottom portion of the implant is missing and not returned for analysis.Optical examination of the thread form did not identify thread damage on the returned portion of the implant.Microscopic examination of the fracture surface appears to emanate from the root of the internal thread tooth outward, is roughly parallel with the tooth angulation, with evidence of linear shear lines on the fracture surface.Functional evaluation found the returned portion of the implant will fully engage onto a sample connector locking screw without issue.The location of the fracture at the base of the connector head, the fracture surface angulation relative to the thread axis, absence of thread damage and direction of shear lines are consistent with torsional overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10598612
• MDR Text Key: 208949742
• Report Number: 1030489-2020-01353
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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
• Device Operator: Health Professional
• Device Model Number: G7753500
• Device Catalogue Number: G7753500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 02/27/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1