MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 6X55; UNKNOWN

Catalog Number 186727655

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

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 Description

Intraoperatively after checking polyaxiality the screw was screwed out with help of the appropriate screwdriver by one turn as per instruction.A clicking sound was heard and a check of the screw showed the inner ring no longer sitting planar in the screw head.Screw was removed and procedure finished with another implant.No surgery delay, no adverse consequences for patient.

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 of the screw revealed that the inner cap (saddle) is dislodged to a certain degree from its intended location.Exerting a significant amount of force on the tulip head and saddle, potentially at a significant angle, may be sufficient to dislodge the saddle.Also, the screw has significant indentation marks and worn threads from the operative usage.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 cannot be determined from the sample and the information provided.A potential root cause may be excessive force inadvertently placed on the drive feature of the screw during tightening, potentially at a significant angle, resulting in the saddle falling apart during use.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: MIS TI CFX FEN POLY 6X55
• Type of Device: UNKNOWN
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7495954
• MDR Text Key: 108159486
• Report Number: 1526439-2018-50458
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 186727655
• Device Lot Number: ATBBZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1