MAUDE Adverse Event Report: DEPUY SPINE INC FEN OPEN CANNULA STRL; DISPENSER, CEMENT

Model Number 279726500

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter: synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was underwent for a percutaneous fixation.The surgeon cemented the screws.When taking out the cannulas, one of the disposable ones was broke and the tip was left inside the screw.The surgeon was failed to take it out due to cement at the bottom of the screw.The patient outcome was unknown.Concomitant device reported: unk - screws: (part# unknown; lot# unknown; quantity: unknown).This is report 01 of 01 of (b)(4).

• Brand Name: FEN OPEN CANNULA STRL
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9682659
• MDR Text Key: 192148893
• Report Number: 1526439-2020-00509
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10705034199528
• UDI-Public: (01)10705034199528
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 01/17/2020
• 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
• Patient Outcome(s): Required Intervention