MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE INSERTER-BAYONET; DRIVER

Model Number	287901009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that the surgeon was performing a l4-s1 posterior lumber interbody fusion on patient on (b)(6) 2019.During procedure surgeon cleared the l4-5 disc space and inserted two (2) 11x13x27 five degree concorde cage of which he removed one which was still on the inserter and attempted to remove the second cage but was unable to do so, instead he tamped this cage farther in.More disc material was removed on one side and then the removed 11x13x27 five degree cage was reinserted.However the inserter snapped off the cage and the surgeon had to remove a black ring from where the cage connected to the inserter and part of the backside of the cage which had broken off into the patient.Surgeon did not want to remove this cage and confirmed that he was happy with the positioning of the cages after image intensifier was taken.Fragments were generated, but were removed easily.There was no surgical delay due to the reported event.Procedure was successfully completed.Patient status/ outcome is unknown.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.(corrected data): adverse event, description of event or problem, type of reportable event: the initial complaint was reviewed and found not reportable.The aei stated the inserter was not broken.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONCORDE INSERTER-BAYONET
• Common Device Name: DRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9370810
• Report Number: 1526439-2019-52485
• Device Sequence Number: 14002575
• Product Code: HWR
• UDI-Device Identifier: 10705034219899
• UDI-Public: (01)10705034219899
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 287901009
• Device Catalogue Number: 287901009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR