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	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One (1) concorde lift driver shaft was returned for evaluation.Visual examination at the macroscopic level revealed a fractured tip at the distal end of the driver.The second half of the tip was not provided for analysis.An optical image of the fractured surface reveals plastic deformation on the top right and bottom left corners along with torsional shear markings following a circular pattern.The plastic deformation of the tip indicates a torsional overload.This suggests the driver underwent a quasi-static overload torsional shear failure starting at the ends of the driver that extended to the center of the shaft, the potential fracture termination site.No material defects or other abnormalities were observed in this analysis.A device history record review identified no issues that could have caused or contributed to the reported event.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 cannot be determined.However, fracture analysis report suggests that the driver underwent a quasi-static overload torsional shear failure starting at the ends of the driver that extended to the center of the shaft, the potential fracture termination site.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.As such, this complaint will be closed with no further action.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 surgeon inserted the lift cage into the disc space, the inserter was at zero.He inserted the driver shaft, started to turn the handle and it was easy for him to turn.It went to max with no resistance.Took an xray and no cage lift happened.He extracted the cage easily thats when we noticed the tip was sheared off in the cage.Opened another cage, inserted and expanded perfect.

• 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: 7597974
• Report Number: 1526439-2018-50548
• Device Sequence Number: 16541640
• Product Code: MAX
• UDI-Device Identifier: 10705034531236
• UDI-Public: (01)10705034531236
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 05/25/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1