MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. FREEDOM RESIDUAL LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	R14-100A130
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during implant procedure the nail was inserted, and when attempting to lengthen with the fast distractor max, the nail would not lengthen.The surgeon also attempted to lengthen with the external remote controller (erc) and the nail still would not move.The nail was then removed and tested with a fast distractor and it still would not move.The procedure was completed using a new nail.
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional data: b5, h3, h6, h10 corrected data: d4 (lot number) device evaluation: visual inspection of the returned nail indicated no damage.X-rays taken of the internal components showed no damage or abnormalities.Stroke testing was performed and confirmed that the device was jammed.Additionally, an audible noise was heard indicating that even though the magnet was spinning no motion was being translated to the lead screw.It is likely that the cause of the reported device jam was due to over-rotation using the manual distractor.Device record review: a review of the device history record (dhr) confirmed that the nail passed all acceptance criteria before being released.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Visual inspection of the returned nail indicated no external damage.An x-ray of the internal components revealed no damage or abnormalities.Stroke testing was conducted, and it was determined that no motion was being translated to the lead screw.The reported issue of the device not distracting was confirmed as the unit was jammed internally.To perform a thorough inspection of the internal components, the unit was then sectioned.Sectioning revealing that the pin was jammed and was being held in place by the lead screw axially pressing on it.Upon closer inspection of the coupler, it appeared that the distraction rod had been retracted and pressed into the coupler¿s top surface.A review of the x-rays from the device history record (dhr) show a small gap between the coupler and the distraction rod, but the x-ray of the returned unit shows no gap which indicated that the distraction rod is in fact pressed on the coupler.These two surfaces were locked together by friction requiring higher torque to unjam the distraction rod.Additionally, the received unit measured at 129.667mm.A review of dhr shows the nail¿s measurement as 129.89mm, showing a difference of 0.223mm, proving that the unit had been retracted.It is likely that the cause of the reported device jamming was due to over retraction.Although it cannot be definitively determined, the over retraction could be caused by using an external remote controller (erc) or fast distractor in the wrong direction.
Event or Problem Description
No additional information has been provided.

• Brand Name: FREEDOM RESIDUAL LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 16897402
• Report Number: 3006179046-2023-00193
• Device Sequence Number: 5956538
• Product Code: HSB
• UDI-Device Identifier: 00812258024239
• UDI-Public: 812258024239
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2023

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: R14-100A130
• Device Lot Number: 3011002AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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
• Patient Age: 23 YR
• Patient Sex: Female