MAUDE Adverse Event Report: SYNTHES USA TI MATRIX LOCKING CAP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.000

Device Problem Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Date 03/13/2015

Event Type  Injury  

Event Description

It was reported that a patient returned to clinic post-operative with a broken left rod which required revision surgery to replace.The patient had a previous matrix pedicle screw construct from t10-ilium; date of the original surgery was unknown.Most of the locking caps used in the original procedure were the cobalt chromium (cocr) locking caps.However, three of the caps used in the original construct were titanium caps.After exposing all of the previous screw heads the final tightener shaft was used in the standard matrix torque t-handle wrench and countertorque to remove all the locking caps in the standard fashion.All of the cobalt chromium caps came out easily but the three titanium locking caps were noted to be stuck.During several of the maneuvers, several of the instruments broke.The surgeon used a solid t25 handle screwdriver through the standard countertorque, to remove the stuck cap.The first cap was removed successfully.During the attempt to remove the second cap, the tip of the screwdriver was worn in the process and was unable to be used further.No pieces were noted in the patient and the driver was removed from the field.This solid screwdriver was replaced with a ratchet t-handle and standard screwdriver shaft to remove the second cap.While trying to remove the second cap, it must have broken the gearing internally because the t-handle all of sudden spun freely and would no longer work.No pieces were noted to be left in the patient and the handle was removed from the field.In its place, a second ratchet t-handle was used and the remaining caps were removed successfully.The left rod was broken just above the left l3 screw-head.After removing the rod on both sides, the surgeon fashioned two new cocr rods to fit.Cocr locking caps were inserted in the usual fashion with a straight t25 driver.During several of the locking cap insertions, the caps fell off of the same driver several times.Upon inspection, it was noted the tip of the driver was worn and should be replaced.The driver was used for the remainder of the case by applying bone wax to the tip to allow the cap to stick.All remaining caps were inserted without event.After the case the driver was removed from the field.The surgeon completed the construct to his satisfaction and the incision was closed.The surgeon did mention the patient was on chronic steroid therapy and the likelihood of fusion was low with this patient.It was reported there was a two to three minute delay in the procedure.This is report 2 of 7 for (b)(4).

Manufacturer Narrative

Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIX LOCKING CAP
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4635210
• MDR Text Key: 16308744
• Report Number: 2520274-2015-12228
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention