MAUDE Adverse Event Report: NUVASIVE, INC. RELINE MAS REDUCER, PILE DRIVER DISM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	D10000482
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive qa for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage technique.A review of the device history record was performed, and no discrepancies were found.A definitive root cause was unable to be determined with the information provided.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"."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"."do not implant the instruments: complications to the patient may include, but are not limited to: breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration.Breakage could cause 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.Surgical grade instrument lubrication should be applied to all moving components during the wash and sterilization cycle to ensure proper functionality.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.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.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 during a posterior fixation procedure while final tightening a lock screw at right l4, the driver tip fractured off and lodged within the lock screw.The fracture reportedly occurred after the associated torque limiting handle did not release the torque as expected, resulting in the surgeon using both hands on the torque handle to tighten the lock screw and leading to the subsequent tip fracture.After an unsuccessful attempt to remove the fractured tip with a magnet, the surgeon decided to leave the tip in-situ, lodged within the lock screw, and proceed with the procedure.There has been no report of adverse patient impact as a result of this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint devices were evaluated and the reported event was confirmed.The evaluation identified the distal hex tip of the pile driver was sheared off; additionally, the t-handle failed torque testing.A review of device manufacturing records was performed and no discrepancies relevant to the reported event were found.The root cause of the fractured tip was determined to be excessive force applied by the user due to the damaged torque handle.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." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".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." ".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." ".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
See h10.

• Brand Name: RELINE MAS REDUCER, PILE DRIVER DISM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18592058
• Report Number: 2031966-2024-00038
• Device Sequence Number: 6857353
• Product Code: LXH
• UDI-Device Identifier: 00887517995452
• UDI-Public: 887517995452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: D10000482
• Device Lot Number: EM41013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• 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: Reuse
• 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: RELINE MAS T-HANDLE, ITEM # 10000606.
• Patient Sex: Female