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

Model Number	188341200
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Udi: (b)(4).One mountaineer head to head cross connector inner screw was returned to the customer quality unit for evaluation on november 2, 2017.The inner screw from lot bdld7va featured approximately one quarter of thread torn off, starting from the distal end.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 inner screw cannot be positively determined.However, the 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
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7017613
• Report Number: 1526439-2017-10977
• Device Sequence Number: 1183566
• Product Code: NKG
• UDI-Device Identifier: 10705034158679
• UDI-Public: (01)10705034158679
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Model Number: 188341200
• Device Catalogue Number: 188341200
• Device Lot Number: BDLD7VA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/14/2017
• Patient Sequence Number: 1
• Patient Age: 53 YR