MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10000750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a posterior fixation from levels l2 to l5 while final tightening the left l2 lock screw, the tip of the final lock screw driver fractured.The fractured piece could not be retrieved and as a result was retained in the patient.No injury and no further patient impact was reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation; however, five (5) photographs of the device provided by the initial reporter were used to confirm the reported event.A visual evaluation of the photographs provided showed evidence of a likely fracture initiation point.The photographs also showed a relatively smooth portion in the center of the fractured surface, which would indicate micro-movement during usage resulting in a fatigue failure after repeated use over time.No photographs of the tip were provided for evaluation and no information on the associated torque handle was provided.Based on the information obtained the root cause of the reported event cannot be determined, but may be the result of a fatigue failure after repeated high-torque use over time.Labeling review: ".Warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Pre-operative warnings.Care should be used in the handling and storage of the reline implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 15655872
• Report Number: 2031966-2022-00219
• Device Sequence Number: 6036459
• Product Code: LXH
• UDI-Device Identifier: 00887517513717
• UDI-Public: 887517513717
• 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): 10/21/2022

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: 10000750
• Device Lot Number: NM3517
• 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: 09/27/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2018
• 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
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG