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 Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
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 driver tip broken during procedure.No adverse consequence to patient.Less than 5 minute delay reported.No fragments left in patient.Details from sales rep: the day before the case rep made sure tether was not stuck.Access and prep was fine.Cage was opened and loaded on inserter, put in disc space, then expanded clockwise and it torqued out immediately.Rep thinks the tether was stuck at zero and this occurred either on the back table or the surgeon turned ccw and jammed it just before trying to expand.Surgeon used a kelly to try and break it free, but confused cw and ccw, and surgeon cranked on it ccw accidentally.Couldn't make it turn cw after this with kelly.Surgeon then grabbed another grabbing type instrument (as sales rep was looking for pliers) and the driver tip broke when tether broke free.Sales rep is not sure if it was going cw or ccw when it broke because he did not see it happen as he was looking for pliers when it occurred.Surgeon was easily able to remove implant, which was still fully collapsed.Replaced with second driver and another implant, which expanded in the same space just fine.Procedure was then completed just fine, both levels without patient harm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was received.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed a fractured tip at the distal end of the driver.Device was sent for analysis.Analysis report found a fully seated shear breakage in the clockwise direction.This was determined by identifying the leading edges that show a chamfer from where the break is initiated.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 tip breaking of the reported concorde lift driver shaft could not be positively determined.However, it can be noted the likely cause is either the implant drive feature was damaged so much that it locked up the implant, or the implant was over collapsed enough to lock up the expansion mechanism, or a combination of these two.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: 7714124
• Report Number: 1526439-2018-50707
• Device Sequence Number: 19149784
• Product Code: MAX
• UDI-Device Identifier: 10705034531236
• UDI-Public: (01)10705034531236
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 06/25/2018

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: 2878-04-101
• Device Catalogue Number: 287804101
• Device Lot Number: NN140448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/07/2018; 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1