MAUDE Adverse Event Report: DEPUY SPINE INC CONF INTRO NDLE, DIA, 11G 4"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	283903411
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Jamshidi needle cannulated sleeve broken and remained in patient l2 right side pedicle.Patient diagnose as l2 pseudarthrosis; bone quality is extremely dense.Doctor tried to create trajectory for packing bonegraft via l2 pedicle to l2 vertebral body by using our jamshidi needle.However, due to bone quality, the needle was unable to pull out after entering patient's l2 pedicle.After several trail, doctors managed to pull out the inner needle and most parts of the cannulated sleeve, and remain ~2 cm broken cannulated sleeve in-situ.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: CONF INTRO NDLE, DIA, 11G 4"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7264707
• Report Number: 1526439-2018-50135
• Device Sequence Number: 19128921
• Product Code: GAA
• UDI-Device Identifier: 10705034209456
• UDI-Public: 10705034209456
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2018

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 Catalogue Number: 283903411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other