MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MOUNTAINEER; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 188341200

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device is available for evaluation.Investigation will be conducted.Follow up will be filed with findings.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Doctor performed a c2-c7 posterior cervical fusion with the mountaineer system on (b)(6) 2017.Once all the screws were in place, he placed the rods and set screws.He decided to do a cross link at the c5 level.He inserted the head-to-head inner screws at this level.A cross link was chosen and placed.When he tried to put the head-to-head outer nuts on, it was decided the cross link needed to be bent.Once it was bent, he tried to put the outer nuts on again.He successfully got both nuts over the cross link.He then proceed to final tighten the outer nuts, one side torqued out with no problems.When trying to final tighten the other side, doctor stated the head-to-head inner screw sheared off.At this point, he removed the cross link and head-to-head inner screws and outer nuts.He decided against placing a new crosslink.

Manufacturer Narrative

Udi: (b)(4).One mountaineer head-to-head cross connector inner screw (product code: 1883-41-200, lot number: bdix2sj) was returned to the customer quality unit (cqu) on september 14th, 2017.The inner screw featured three sections of thread that were missing from the bottom of the screw.All of these sections were aligned vertically and cover approximately 1/6th of a full rotation.The controlled manner of the damage is indicative of the inner screw being tightened into the outer nut while cross threaded.Tightening the inner screw while it is cross threaded can lead to stress building up on the thread, resulting in part of the thread splitting off from the body of the inner screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the threads of the inner screw breaking cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading the inner screw during insertion into the outer nut.This would place stress on the threads of the inner screw, potentially resulting in them becoming damaged or torn.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MOUNTAINEER
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6910559
• MDR Text Key: 88023914
• Report Number: 1526439-2017-10791
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034158679
• UDI-Public: (01)10705034158679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

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: Physician
• Device Model Number: 188341200
• Device Catalogue Number: 188341200
• Device Lot Number: BDIX2SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1