MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT DRIVER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2878-04-101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported during the case the reason concorde lift expandable interbody cage, physician wanted to reposition the cage.It wasn't done far off, so he collapsed and while he is attempting to collapse the cage about halfway through the driver tip (2878-04-101) broke off inside the implant.We were able to fully collapse the implant and removed the implant (1978-09-021c).We used another implant and a fresh driver and were fine.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (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 returned device found that fully seated shear breakage occurred in the counter clockwise direction.This suggests that the cage was being collapsed at point of failure.This was determined by identifying the leading edges that show a chamfer from where the break is initiated.The fracture analysis report reveals plastic deformation on the top right and bottom left corners along with torsional shear markings following a circular pattern.This suggests that the driver underwent a quasi-static overload torsional shear failure.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 concorde lift driver tip fracturing cannot be positively determined.However, the fracture analysis of the device suggests that driver tip underwent a quasi-static overload torsional shear failure.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: CONCORDE LIFT DRIVER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8333105
• Report Number: 1526439-2019-51341
• Device Sequence Number: 16390143
• Product Code: MAX
• UDI-Device Identifier: 10705034531236
• UDI-Public: (01)10705034531236
• Combination Product (Y/N): N
• PMA/510(K) Number: K173537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2019

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: 2878-04-101
• Device Catalogue Number: 287804101
• Device Lot Number: NN140448R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/20/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1