MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE GENERAL INSTRUMENTS; ORTHOPEDIC MANUEL SURGICAL INSTRUMENTS

Model Number	6973403
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned for evaluation and no radiographs were provided to confirm the unretrieved fragment.A review of the manufacturing history found no material nonconformance, no manufacturing error, nor discrepancies with respect to material type, treatments or dimension that may have caused or contributed to this event.Parts met acceptance criteria upon release.The reported information suggests off-angled excessive force as the root cause.No additional investigation can be completed at this time, should more information be received a follow-up report will be completed.Label review: ".Residual risks - 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 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.".".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".".Intra-operative warnings - the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.".".Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.".
Event or Problem Description
On (b)(4) 2022 an anterior lateral interbody fusion procedure from l5 to s1.During the procedure the tip of the pin fractured off in the patient inside the right s1 vertebral body flush with the bone.The surgeon was aware and opted for reasons of safety not to remove it.There were no adverse consequences to the patient and the surgery was completed without issue.

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUEL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15978564
• Report Number: 2031966-2022-00284
• Device Sequence Number: 6894485
• Product Code: LHX
• UDI-Device Identifier: 00887517840103
• UDI-Public: 887517840103
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/14/2022

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: 6973403
• Device Lot Number: 357046
• 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: 11/28/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose