MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP; INSTRUMENT, BIOPSY

Model Number	DJ4011X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported via email: that a small portion had fractured in the vertebral body of si and could not be retrieved.It was reported via email: a jamshidi bone marrow biospy /aspiration needle was then utilized at the left si pedicle vertebral body.The patient had very hard bone.In trying to reposition the jamshidi instrument, a small portion had fractured in the vertebral body of si and could not be retrieved and was left in the vertebral body on the left side at si.The broken piece measured roughly 2.5 cm.What was the original intended procedure?: 14-si non invasive percutaneous pedicle screw instrumented fusion utilizing spineology palisade.L4-s1 arthrodesis.L5 laminectomy.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: (b)(4) photos displaying a needle and product label for a similar device were provided, there was no evidence of damage or other defects on the device within the photo.As no photos or physical samples that display the reported condition were available for investigation, we cannot verify the reported failure.Product undergoes visual and functional inspections throughout manufacturing according to procedure, as the lot involved in this incident is unknown, a device history review cannot be performed.Based on the available information, we cannot identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer narrative.
Event or Problem Description
It was reported via email: that a small portion had fractured in the vertebral body of si and could not be retrieved it was reported via email: a jamshidi bone marrow biospy /aspiration needle was then utilized at the left si pedicle vertebral body.The patient had very hard bone.In trying to reposition the jamshidi instrument, a small portion had fractured in the vertebral body of si and could not be retrieved and was left in the vertebral body on the left side at si.The broken piece measured roughly 2.5 cm.What was the original intended procedure? : 14-si non invasive percutaneous pedicle screw instrumented fusion utilizing spineology palisade.L4-s1 arthrodesis, l5 laminectomy.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 11114653
• Report Number: 9680904-2020-00048
• Device Sequence Number: 19731922
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: DJ4011X
• Device Catalogue Number: DJ4011X
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR