MAUDE Adverse Event Report: SYNTHES (USA) MONUMENT 6.0MM TI HARD ROD 150MM

Catalog Number 498.106

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported a patient had posterior l2-s1 fusion with synthes universal spine system dual opening system on an unknown date in (b)(6) 2012.On an unknown date about two weeks prior to (b)(6) , 2014 the patient bent over and he heard and felt something.The patient returned to the clinic and upon examination, the surgeon observed the bilateral rods had broken just above the l4 screws; he also diagnosed a l3-l4 non-union.The patient was returned to the operating room on (b)(6) 2014, where the surgeon removed all universal spine system dual opening hardware from the 2012 surgery.He placed new, larger universal spine system dual opening screws and two new rods, and connected the construct.While inserting the new screws, the surgeon required a lot of torque to place them properly.While placing the left s1 screw, the hook/screw holder with 4.0 millimeter hex (part number 388.612) broke off in the screw.The broken fragment was retrieved from the screw easily.There was about a 10 minute delay in the procedure.The surgery was successfully completed.The patient status/outcome following the procedure was not provided.This is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was requested; however, lot number provided 6572351 is not a valid synthes lot number for this part.There is no synthes cross-reference lot number for lot number 6572351, for part number 498.106; therefore, a dhr review is not possible.Implant date: (b)(6) 2012.Device was used for treatment, not diagnosis.Placeholder.

Manufacturer Narrative

A product development event evaluation was performed.Drawings for the hook/screw holder were reviewed as a part of this evaluation.These drawings were found suitable to determine the intended device design, application and dimensional conformity.The hook/screw holders were found to have met the drawing specifications.After reviewing the related product drawings, the complaint is deemed to be indeterminate from a product design perspective.The complaint description states that ¿while inserting the new screws, the surgeon required a lot of torque to place them properly¿.The application of excessive torque directly led to both instrument failures.The need to apply excessive torque could be caused by high bone density which would require extra force to seat the screw in the patient¿s pedicle.It is also possible that the pedicle was not prepared properly, causing a situation which necessitated excessive torque to insert the screws.As additional information as to the preparation of the patient¿s pedicles was not provided, the complaint is considered indeterminate.(b)(4).

• Brand Name: 6.0MM TI HARD ROD 150MM
• Manufacturer (Section D): SYNTHES (USA) MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES (USA) MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3591484
• MDR Text Key: 16011037
• Report Number: 2520274-2014-00260
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.106
• Device Lot Number: 6572351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 01/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 108