MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE UNIVERSAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1001992
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation; the reported fracture was confirmed by review of photographs of the device.No operative notes and/or radiograph images were provided for review of usage/technique.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Residual risks to the patient associated with use of general surgical instruments are: instrument malfunctions which potentially result in surgical delays (thereby causing additional exposure to anesthesia, blood loss, and infection), a change in surgical plan, failure to achieve optimal clinical result and/or, infrequently, cancellation of a procedure.Such malfunctions include instrument fracture, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration; instrument fracture may also result in injury to the patient." ".Pre-operative warnings: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.The instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury." ".Intra-operative warnings: the physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial two (2) level extreme lateral interbody fusion procedure at l3/4 and l4/5.During the procedure, when the paddle sizer was inserted into the intravertebral space and slightly twisted, the attached hudson t-handle fractured at the mating interface with the paddle sizer.The fractured portion was searched for but was unable to be located within the patient.Information regarding whether images were used to confirm if the piece was in the patient or not was requested but was not available.Therefore, it could not be determined if the fractured piece was retained by the patient.No additional information is available.

• Brand Name: NUVASIVE UNIVERSAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 16958118
• Report Number: 2031966-2023-00110
• Device Sequence Number: 12071722
• Product Code: LXH
• UDI-Device Identifier: 00887517045928
• UDI-Public: 887517045928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: 1001992
• Device Catalogue Number: N/A
• 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: 04/25/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK PADDLE SIZER
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 59 KG