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

Model Number	188319328
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	03/05/2018
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 spinal fusion surgery for odontoid process fracture was performed by using the mountaineer spine system.The fixed area was c2-c3.The surgeon noticed that the surgeon had a difficulty in taking the driver bit off from one screw.When the rod was placed, the rod could not be placed within the head.When checked, it was found that the clamp part between the screw head and screw was standing out.Another new screw was used to complete the procedure.The surgery was completed with a delay (less than 30 minutes), 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.The returned polyaxial screw¿s saddle had completely come out of the tulip head.The screw shank and tulip head remained attached.All of the parts remain in good condition.There are no immediately observable tool marks to any of the components beyond wear to the screw¿s drive feature.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.The root cause of the saddle being forced out of the tulip head cannot be determined from the sample and the information provided.A potential root cause may be excessive force placed on the polyaxial screw during tightening.This may have occurred if high amounts of stress were placed on the screw¿s saddle, especially at an extreme angle in relation to the adjacent components of the 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 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 M/L SCREW 3.5 DIA X 28
• 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: 7465215
• Report Number: 1526439-2018-50410
• Device Sequence Number: 931583
• Product Code: NKG
• UDI-Device Identifier: 10705034157696
• UDI-Public: (01)10705034157696
• 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): 03/05/2018

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: 188319328
• Device Catalogue Number: 188319328
• Device Lot Number: APBCZJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1