MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR F/A SCREW 3.5DIA X 28MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188318328
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
On (b)(6) 2018, the surgery for the cervical opll was performed by using the mountaineer system.The fixed area was c2 ¿ 5.The reported favored angle screw was used when the surgeon was inserting the c2 lamina screw.When the surgeon installed the screw to the driver, there was no problem.When the surgeon removed the screw from the screw driver, since the surgeon pushed the button on the driver inner portion, the screw could not be detached from the screw driver.The surgeon installed the screw to the screw driver again.However, the surgeon pushed the button on the driver inner portion three times and repeated the screw installation, the inner part of the screw head was come up; thus, the surgeon could not place the core driver or the rod anymore.The surgery was completed with a 30-minute-delay, and there was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination found that the polyaxial¿s tulip head inner cap had become rotated out of position.No damage was present on the polyaxial screw shank.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head.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 polyaxial¿s inner cap becoming rotated out of position cannot be positively determined.However, it is suggested that unanticipated high amount of forces was placed on the tulip head resulting in the inner cap becoming rotated out of position.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.

• Brand Name: MNTR F/A SCREW 3.5DIA X 28MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7515767
• Report Number: 1526439-2018-50465
• Device Sequence Number: 19458140
• Product Code: NKG
• UDI-Device Identifier: 10705034157252
• UDI-Public: (01)10705034157252
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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 Model Number: 188318328
• Device Catalogue Number: 188318328
• Device Lot Number: AKDDFR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1