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	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The concorde lift driver shaft was not returned to the customer quality unit for evaluation.A review of the device history record (dhr) for the concorde lift driver shaft could not be performed as a lot number was not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the concorde lift driver shaft we are unable to confirm the reported issue or identify the root cause.As the device failure cannot be confirmed, the complaint will be closed with no further action required at this time.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 at the (b)(6) hospital, dr.(b)(6) concorde lift lordotic expandable cage was used at l1-l2 level to create lordosis in a patient with severe flat back.The disc space was created using shavers and then pituitaries and curettes.We were able to get a 10 mm shaver in the disc space and then a lordotic trial for the 10 mm height of the concorde lift lordotic cage.The implant was inserted in the disc space and the driver shaft was then inserted into the insertion holder.Driver shaft was clearly inserted into device demonstrated by the line on the shaft.Driver handle immediately torqued out as disc space was tight to begin with.Doctor held handle and top part of driver shaft and turned again.At this point the driver expansion tip broke off at distal end.About 1-2 mm of the distal tip.We were able to remove driver fragment easily with suction and then tried again with back-up driver shaft.Again, handle immediately torqued out with no expansion.Disc space was tight to begin with so no surprise.No harm whatsoever to patient and no delay to the case.Broken driver shaft was set aside for return but was then mistakenly discarded by surgical scrub tech after the case and was not able to be recovered.Sales rep has requested replacement driver shaft and that has been granted.

• 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: 7635396
• Report Number: 1526439-2018-50585
• Device Sequence Number: 2482260
• Product Code: MAX
• UDI-Device Identifier: 10705034531236
• UDI-Public: (01)10705034531236
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1