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	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Dhr review: this lot was quarantined in late april 2017 when the non-conformance was detected and the nc was dispositioned and closed by may 3rd.The non-conformance that this lot was quarantined for was dispositioned use as is, thereby making it acceptable product.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
Once the cage was placed and confirmed under fluoroscopy, surgeon proceeded to expand the cage with the driver shaft and torque limiting handle.The torque limiting handle torqued out once the cage was raised to desired height.When the shaft/handle combo was removed from inserter, surgeon noticed the driver tip had sheared off.Surgeon used a metal cutting midas tip to try and recover the broken fragment but was unsuccessful.
Additional Manufacturer Narrative
The concorde lift driver shaft was returned for evaluation.Visual inspection noted that the driver was broken at its distal tip.Optical imaging, on same devices of the same lot, found evidence of a quasi-static torsional overload.These findings were replicated using the destructive testing performed on the driver returned for this complaint.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively determined however fracture analysis conducted on same devices of the same lot found evidence of torsional overload.This is likely due to higher than expected forces being placed on the driver tip during tightening.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 have been observed, 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: 6767710
• Report Number: 1526439-2017-10631
• Device Sequence Number: 11140251
• Product Code: MAX
• UDI-Device Identifier: 10705034531243
• UDI-Public: (01)10705034531243
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/19/2017

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: 07/24/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/12/2017
• Patient Sequence Number: 1