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

Model Number	P12.5-80B305
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a few months ago something snapped in the patient's leg while stretching and the physician suspects a crown breakage.It was additionally reported that the nail has recoiled and caused a rotational deformity.No additional information has been provided.
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.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
Lot numbers 1030506aaa and 2031411aaa were provided, however, it is unknown which lot number belongs to the nail in question.A review of the device history record(s) confirmed the device met all quality inspections and specifications prior to release.
Event or Problem Description
Additional information has been provided.
Additional Manufacturer Narrative
The nail was not returned to nuvasive for evaluation.This investigation was conducted based on the provided x-ray image.Based on the image the loss of distraction was unable to be confirmed, however, a small piece of material is visible between the distraction rod and housing where the break likely occurred.Additionally, the aluminum-bronze nut appears to be backed out.This may have been caused during the exercise session, stretched leg crossed over another, when the patient felt something snap.It is likely excess weight was bearing on the nail.Device labeling: per the instructions for use (ifu) "the nail cannot withstand the stresses of full weight bearing for tibia and femur applications".
Event or Problem Description
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: 17052303
• Report Number: 3006179046-2023-00267
• Device Sequence Number: 6965909
• Product Code: HSB
• UDI-Device Identifier: 00812258020347
• UDI-Public: 812258020347
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2023

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: P12.5-80B305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 07/26/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male