MAUDE Adverse Event Report: DEPUY SPINE INC X-MESH PISTOL INSERTER/EXPANDE; DRIVER, PROSTHESIS

Catalog Number	288900000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that a spinal surgery(not a revision) took place on (b)(6) 2018 where the following events happened with set # xmpc-40: 1.Part # 2889-00-000 lot br607613 cage could not be implanted as the inserter broke.2.Part #1889-01-233 lot bdc13sg failed to lock 3.Part #1889-01-028 lot bdcg3tk broke.4.Part # 1889-21-028 lot bdjf3sc would not release from driver.There were alternate parts available to complete the surgery.As a result of the reported issues, the patient consequences were as follows: 1.A prolonged surgery of 90 minutes.2.The vena cava was torn and had to be repaired.3.Loss of blood due to multiple attempts to complete the surgery.Surgeon report may be available in the near future.
Additional Manufacturer Narrative
(b)(4).It was noted that the expansion arms sub assembly was loose and was able to shift position/angle without input.Visual examination revealed that the expansion arms sub assembly was missing a screw which holds the arms of the sub assembly together.The screw was not returned to customer quality unit.There is no evidence of any breakage on the device.The expansion knob mechanism, release lever and pistol grip were functioning as intended.The gold sleeve which allowed the handles rotate and lock in at 90 degree intervals was functioning as intended.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for missing a screw which holds the arms of the sub assembly together cannot be positively determined with the information provided.However, noted damage suggests that the inserter/expande was likely subjected to unanticipated overloading forces while expanding the cage to the desired height, resulting in a screw which holds the arms of the sub assembly together falling apart.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: X-MESH PISTOL INSERTER/EXPANDE
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7826070
• Report Number: 1526439-2018-50816
• Device Sequence Number: 16596345
• Product Code: HWR
• UDI-Device Identifier: 10705034222592
• UDI-Public: (01)10705034222592
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 288900000
• Device Lot Number: BR607613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR