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

Model Number	279726508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10032707
• Report Number: 1526439-2020-00935
• Device Sequence Number: 2714976
• Product Code: KIH
• UDI-Device Identifier: 10705034199566
• UDI-Public: (01)10705034199566
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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 Model Number: 279726508
• Device Catalogue Number: 279726508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention