MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MNTR F/A SCREW 3.5X14; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	188318314
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).The mntr f/a screw 3.5x14 was returned to the customer quality unit (cqu) for evaluation.Visual evaluation of the mntr f/a screw 3.5x14 showed that the thread in the head of the screw driver was torn.A device history review was performed.No discrepancies were observed during the manufacturing process.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the threads on the head of the 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 head of the screws causing it to be torn.No issues could be identified in the manufacturing or release of this device.Therefore, this complaint 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 F/A SCREW 3.5X14
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7260645
• Report Number: 1526439-2018-50123
• Device Sequence Number: 1157987
• Product Code: NKG
• UDI-Device Identifier: 10705034157184
• UDI-Public: 10705034157184
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K041203
• 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): 02/08/2018

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: 188318314
• Device Lot Number: 151521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 02/08/2018
• 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