MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P8.5-50M165
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the nail fell apart during explantation and subsequently the bone needed to be fenestrated.The remaining part of the nail was unable to be removed, as it was too tight in the bone, resulting in some parts of the nail remaining in the bone.Due to the break, the patient's treatment will be extended 6 weeks.Currently the patient walks on their forearms.No additional information has been provided.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
Device evaluation: a review of the patient x-rays visually confirms that the distraction rod was still in the femur at the time of imaging.Visual inspection of the returned device confirms that the distraction rod is missing.In reviewing the device x-rays taken as part of investigation and the provided clinical x-rays, it was determined that the nail separated at the junction of the lead screw and lead screw coupler due to a retaining pin failure.Functional testing was unable to be performed due to the device being returned in an inoperable state (missing distraction rod).As part of the explantation process technique, the surgeon attaches a removal rod and tapered extractor to the proximal end of the implant and then gently backslaps the assembly with a slotted mallet, such that the device slides smoothly out of the intermedullary canal.Narrowing or hardening of the intramedullary canal and/or bone growth around the distraction rod¿s distal tip can hold the distraction rod in place, creating resistance during the removal process and requiring the surgeon to apply greater forces during the removal.Additionally, a bulb feature is present at the distal tip of the distraction rod.The bulb feature is larger in diameter than the distraction rod, potentially needing a wider and softer intermedullary canal surface for removal.It was reported the distal portion of the nail could not be explanted due to it being too tight in the intramedullary canal.It should be noted that the nail was implanted for approximately three years (this implant is indicated for a one-year implantation time per the device's instructions for use (ifu), which was current at the time of implantation).Although a definitive root cause of the event is unable to be determined, it is possible that the length of time the nail was implanted may have caused or contributed to the nail dissociation and the reported bone damage.The implantation time of approximately three years may have been enough time for the intermedullary canal to shrink/narrow and harden into bone and thus would make it more difficult to remove the implant, resulting in the reported bone damage and requiring increased force to remove the nail, which may have overcome the load bearing capability of the retaining pin, causing it to fail and allow the separation of the nail housing and distraction rod.Device labeling: "device should be removed after implantation time of no more than one year".
Event or Problem Description
Information was received that the nail disassembled during explantation and subsequently the femoral bone needed to be fenestrated due to bone damage incurred during the removal process.The distal portion of the disassembled nail was unable to be removed from the intramedullary canal as it was reportedly too tight in the bone.Due to the bone fenestration, the patient's hospital stay was extended six weeks and required the patient to walk with forearm support.No additional information has been provided.

• Brand Name: PRECICE 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: 17614745
• Report Number: 3006179046-2023-00331
• Device Sequence Number: 20506048
• Product Code: HSB
• UDI-Device Identifier: 00812258028237
• UDI-Public: 812258028237
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P8.5-50M165
• Device Lot Number: 9012114AAA
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 40 KG