MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MNTR H/H X-CONN INNER SCREW; MOUNTAINEER OCT SPINAL SYSTEM

Catalog Number	188341200
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual evaluation of the returned device showed that the thread on screw was torn.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the threads becoming torn cannot be positively determined at the moment.The likely cause of the defect is the instrument being subjected to unanticipated high amount of forces during use.This will put too much pressure on the threads on the screw causing it to be 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 were found, 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.
Event or Problem Description
It was reported surgeon could not final tighten the outer nuts on top of the crosslink because the tall set screw threads had been sheared and he could not final tighten the inner crosslink set screw.Appears the screw and the inner set screw were cross threaded.

• Brand Name: MNTR H/H X-CONN INNER SCREW
• Common Device Name: MOUNTAINEER OCT SPINAL SYSTEM
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7260591
• Report Number: 1526439-2018-50120
• Device Sequence Number: 19053188
• Product Code: KWP
• UDI-Device Identifier: 10705034158679
• UDI-Public: 10705034158679
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: Health Professional
• Device Catalogue Number: 188341200
• Device Lot Number: BDLD6SV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR