MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; SPINAL TRAY

Model Number	DYNJRA1790
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2022, a "spinal needle was inserted at l3-l4, the stylet was removed and then the os was encountered.Attempted to withdraw the whitacre and introducer needle.At that point, the distal 1/3 of the whitacre needle was noted to be missing." the customer reported that the retained needle was confirmed with an x-ray.According to the customer a 'neurosurgeon' was consulted and the patient required 'surgical intervention' to remove the retained needle.The customer reported the 'c-section' was able to be completed by 'placing a second spinal attempt'.Sample is not available to be returned.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, a "spinal needle was inserted at l3-l4, the stylet was removed and then the os was encountered.Attempted to withdraw the whitacre and introducer needle.At that point, the distal 1/3 of the whitacre needle was noted to be missing." the customer reported that the retained needle was confirmed with an x-ray.

• Brand Name: Medline Industries, Inc.
• Common Device Name: SPINAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16130600
• Report Number: 1417592-2023-00020
• Device Sequence Number: 16941005
• Product Code: OJH
• UDI-Device Identifier: 10193489880441
• UDI-Public: 10193489880441
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: DYNJRA1790
• Device Catalogue Number: DYNJRA1790
• Device Lot Number: 22GLA001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown