MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM; DISPENSER, CEMENT

Catalog Number	279726500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on (b)(6) 2024, during a posterior fusion with a fenestrated screw, when using the syringe in the syringe kit and the confidence adapter, the surgeon tried to attach it to the open cannula, but it did not fit properly.A new open cannula was opened.The surgery was completed successfully with no surgical delay.The patient was reported as stable.This report involves one (1) expedium spine system fenestrated screw open cannula 16g x 160mm.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Device history review (dhr): a review of the receiving inspection (ri) for fen open cannula strl, was conducted identifying that lot number lc42103 was released in one batch.Batch1: lot qty of (b)(4) units were released on oct 13, 2023 with no discrepancies.Supplier : (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19760719
• Report Number: 1526439-2024-01848
• Device Sequence Number: 8624870
• Product Code: KIH
• UDI-Device Identifier: 10705034199528
• UDI-Public: (01)10705034199528(17)280731(10)LC42103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 279726500
• Device Lot Number: LC42103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS
• Patient Sex: Unknown