MAUDE Adverse Event Report: DEPUY SPINE INC CONF INTRO NDLE, DIA, 13G 4"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283903413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), unknown.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
It was reported that on (b)(6) 2019, during a vertebral body augmentation (vba) procedure, the surgeon encountered a sclerotic bone which made it very difficult to pull out the introducer needle.During his attempts to pull it out of the vertebrae, the needle broke from its handle.He later succeeded to pull out the needle itself from the patient and the patient was not harmed.Surgical delay and procedure outcome is unknown.There was no patient consequence.This complaint involves one (1) device.

• Brand Name: CONF INTRO NDLE, DIA, 13G 4"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8781592
• Report Number: 1526439-2019-51827
• Device Sequence Number: 2321061
• Product Code: GAA
• UDI-Device Identifier: 10705034209463
• UDI-Public: (01)10705034209463
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 283903413
• Device Catalogue Number: 283903413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1