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

Model Number	P8.5-80D245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the patient was weightbearing daily and they felt a snap.The nail subsequently broke and the patient required a revision procedure to remove the device.
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause cannot be confirmed at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
Device evaluation: the nail was returned to nuvasive for evaluation.Upon initial visual inspection, it was confirmed that the implant was broken.It was also visibly bent and completely sheared from the housing tube to the internal mechanism (broken coupler).X-ray analysis pinpointed the break just above the gear train assembly.No functional testing was conducted due to the state in which the device was returned.Because it was noted that the patient was fully weight bearing, this would help to explain the fatigue that was observed on the device.The break was at the location of the bend, indicating that the fracture most likely occurred over repeated bending forces possibly associated with weight-bearing activities.Device labeling: per the precice instructions for use (ifu), ¿the precice intramedullary limb lengthening nail cannot withstand the stresses of full weight bearing for tibia and femur applications.Patients should utilize external support and/or restrict activities until consolidation occurs.¿.Device record review: a review of the device history record (dhr) indicates the device was manufactured by the specified requirement at the time and met all of the required inspections before shipment.
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: 18312411
• Report Number: 3006179046-2023-00358
• Device Sequence Number: 6643590
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 812258020606
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: P8.5-80D245
• Device Lot Number: 2052406AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 50 KG