MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONCORDE LIFT INSTRUMENTS DRIVER SHAFT -AO; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2878-04-101G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A follow up report will be filed upon completion of the investigation.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
Final tightening with torque limiting handle.Did not get expansion wanted.Switched to static black handle shaft broke immediately.
Additional Manufacturer Narrative
Visual examination of the returned device found the distal tip was broken off.Device was subsequently sent for fracture analysis.Fracture exhibited a rotational pattern consistent with torsional overload of the driver.No evidence of material or manufacturing defects or anomalies were observed.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.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause for concorde lift driver shaft breaking cannot be determined from the sample and information provided.However, the fracture analysis report suggests torsional overload of the driver.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 INSTRUMENTS DRIVER SHAFT -AO
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6751072
• Report Number: 1526439-2017-10615
• Device Sequence Number: 652760
• Product Code: MAX
• UDI-Device Identifier: 10705034531243
• UDI-Public: (01)10705034531243
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 07/06/2017

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: Physician
• Device Model Number: 2878-04-101G
• Device Catalogue Number: 287804101G
• Device Lot Number: 052316-A R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/29/2017
• Patient Sequence Number: 1
• Patient Age: 52 YR