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

Model Number 188341100

Device Problem Torn Material (3024)

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

Event Date 10/16/2017

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

When torquing down the outer nut on the h/h conn plate, the driver and nut kept shearing off the top of the inner screw.The surgeon was not able to use the h/h conn plate in his construct because of this.

Manufacturer Narrative

Udi: (b)(4).One mountaineer head to head cross connector outer nut was returned to the customer quality unit for evaluation on november 2, 2017.The outer nut from lot bdld7t5 featured a loose length of thread approximately as long as the thread missing from the inner screw.It is believed that this is the thread from the damaged inner screw.This damage may have occurred due to cross threading the outer nut on the inner screws upon insertion.Tightening an outer nut while it is cross threaded places an unexpectedly high amount of force on the threads of both the nut and the inner screw, resulting in them being damaged or torn.This event was not influence by the tightener, which was operating within specification.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 for the damage to the threads of the outer nut cannot be determined.However, this damage may have occurred due to inadvertently cross threading the outer nut onto the inner screws upon insertion.Tightening a nut while is cross threaded places an unexpectedly high amount of force on the threads of both the outer nut and inner screw.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: 7017543
• MDR Text Key: 92663585
• Report Number: 1526439-2017-10976
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034158662
• UDI-Public: (01)10705034158662
• 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: 10/16/2017

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: 188341100
• Device Catalogue Number: 188341100
• Device Lot Number: BDLD7T5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR