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

Model Number 279726508

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

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 during an unknown procedure part of the cannula was broke and stayed inside the patient as it couldn¿t extracted anymore.The outcome of procedure and the patient was unknown.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: FEN MIS 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: 10032707
• MDR Text Key: 193432388
• Report Number: 1526439-2020-00935
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10705034199566
• UDI-Public: (01)10705034199566
• Combination Product (y/n): N
• Reporter Country Code: LU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279726508
• Device Catalogue Number: 279726508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2020
• 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