MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE PULSE SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	1840160
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 during post-case monitoring removal the wire disconnected from the needle tip/connector and was left in the tape.When the operator was removing the tape they were stuck by the needle.No blood test results available at this time.
Additional Manufacturer Narrative
No product returned for examination due to infection protocol though photograph provided confirmed the event.Review of the photograph and information provided identified the operator pulled the lead wire while taped instead of gripping the connector, creating excessive force and subsequent disconnection.The root cause of this event appears to be the result of poor handling by the end user.No additional investigation can be completed.Labeling review: ".Warnings, cautions and precautions: do not attempt to straighten bent needles because this may cause stress and weaken the needle causing it to break off in the patient.Needles are sharp and extreme care must be taken during handling.Improperly placed or bent needles increase the risk of needle breaking off in the patient." ".Precaution: pull cable connections apart by gripping the connector.Do not pull them apart by tugging on the cable as this can damage the connecting cable.Never force a connection or a disconnection.".

• Brand Name: NUVASIVE PULSE SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13446808
• Report Number: 2031966-2022-00027
• Device Sequence Number: 19360626
• Product Code: OLO
• UDI-Device Identifier: 00887517818997
• UDI-Public: 887517818997
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1840160
• Device Lot Number: 1096176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose