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

Model Number 279726500

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2023

Event Type  Injury  

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.Device available for evaluation: 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 Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2023 a spinal fusion (t9 to l1) for the t11 vertebral body fracture with screw insertion (viper prime fenestrated screw) and cement was performed.The patient has bone fragility.The event took place in sequence as follows: 1.The open cannula was inserted directly into the screw because alignment devices for the purpose of preventing shaking of the open cannula has not been arranged.Then, the cement was injected.2.The screw was inserted one by one under checking the image.3.The tip of the open cannula broke off during cement injection into the last t9 right screw.The broken tip remained in the hollow of the screw and was surrounded by cement.The broken tip was not seen floating in the patient body, and there were no problems with rod installation.No health hazard reports to the patient.This report is for an expedium spine system fenestrated screw open cannula 16g x 160mm.This is report 1 of 1 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16362154
• MDR Text Key: 309380784
• Report Number: 1526439-2023-00236
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10705034199528
• UDI-Public: (01)10705034199528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279726500
• Device Catalogue Number: 279726500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: VIPER PRIME.
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Male