MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONCORDE LIFT INSTRUMENTS TORQUE LIMITING HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2878-04-102
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lot unknown.Awaiting sample: 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.Device not yet returned for evaluation.
Event or Problem Description
On (b)(6) 2017 dr.(b)(6) performed a l4-s1 posterior lumbar fusion.Dr.(b)(6) placed concorde lift cages at l4-l5, and l5-s1.While performing the l4-l5 level of interbody fusion with concorde lift, the concorde lift driver shaft broke (2878-04-101g).At the l4-5 level, dr.(b)(6) placed a concorde lift lordotic 9 mm x 23 mm cage (us-1978-09-023l).While distracting the cage with the torque handle, he torqued out the cage.He then tried to expand the cage a little more by slowly turning the torque handle.He tried this several times.On about the 4th time, the tip of the driver shaft broke.It was the very tip of the driver that broke, approximately 1 mm.He was able to retrieved the driver fragment by suctioning it out.This small piece was somewhere in the suction canister and not available to send back.The driver shaft will be sent back.Dr.(b)(6) got about 2.5 mm of distraction out of the cage.The procedure was successfully completed with no harm to the patient.
Additional Manufacturer Narrative
The concorde lift torque handle was returned for evaluation.Bench top torque testing found the device to be functioning within its intended specifications.No product problem was identified with this device.This device is considered concomitant and did not cause or contribute to the reported event.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.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.
Additional Manufacturer Narrative
Additional evaluation conducted by npd found the color wheel inside the handle had melted during autoclave and adhered to the plastic inside.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 TORQUE LIMITING HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6744653
• Report Number: 1526439-2017-10618
• Device Sequence Number: 19106404
• Product Code: LXH
• UDI-Device Identifier: 10705034531373
• UDI-Public: (01)10705034531373
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 06/29/2017

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: 2878-04-102
• Device Catalogue Number: 287804102
• Device Lot Number: 041117A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 08/28/2017; 10/10/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/28/2017; 10/16/2017
• Patient Sequence Number: 1
• Patient Age: 50 YR