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	Foreign Body In Patient (2687)
Date of Event	08/01/2018
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 that the tips broke off on two concorde lift devices during a l5-s1 tlif on (b)(6) 2018.As the surgeon was positioning the device in the l5-s1 disc space, the driver torqued out.The surgeon then took a needle driver and further turned the driver past its torque limit, and the tip snapped off.The tip remained in the implant.The surgeon pulled the driver out and was finished with that portion of the case.The surgeon then moved to another level, at l4-l5.The surgeon wanted more distraction, so he used another of the same type of driver.He took a heavy needle driver to get more distraction and the tip of the second driver also broke.The broken tip of the second device remains in the implant at l4-l5.There was no reported surgical delay, no additional x-rays or other medical intervention required.The procedure was completed successfully with the patient in stable condition.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed a fractured tip at the distal end of the driver shaft.The second half of the tip was not provided for analysis.A fracture analysis was conducted on the returned device.It was noted in the fracture analysis report reveals plastic deformation on the top left and bottom right corners along with torsional shear markings following a circular pattern.The plastic deformation of the tip indicates a torsional overload.This suggests that the driver shaft 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 driver shaft distal tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the driver 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.Alleged failure.

• 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: 7804389
• Report Number: 1526439-2018-50809
• Device Sequence Number: 1536406
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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: 08/17/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR