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

Model Number	P12.5-80D305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation as it was discarded.A definitive root cause is unable to be determined at this time but is likely related to the reported patient engaging in full weight bearing on the nail before adequate bone consolidation had occurred.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.
Event or Problem Description
Information was received that the nail fractured in-situ.The patient was reportedly engaging in full weight-bearing on the nail without bone consolidation strong enough to support normal gait movement.The patient claimed they felt a pop during movement and the nail was subsequently found to have a clean break through the center of the nail at the site of original osteotomy.The patient underwent a revision surgery; however, no further adverse impact to the patient was reported.No additional information is available.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
The unit was not returned to nuvasive for direct investigation.During evaluation of the provided x-ray, it was noted that the unit¿s housing tube has broken at the middle of the nail which confirms the reported failure.The work order has been reviewed and confirmed the device passed all inspections per the acceptance tests.The inspection data for the lot of housing tube was reviewed and confirms the parts met design specifications per the engineering drawings.Therefore the breakage was not determined to have been related to the manufacturing processes or material failure.Based on the provided information and the type of breakage observed, it is probable the nail broke due to stress generated from weight bearing activities.Device labeling: per the precice instructions for use, "the precice intramedullary limb lengthening nail cannot withstand the stresses of full weight bearing for tibia and femur applications.For humerus applications, patients should not bear any weight on the treated limb.Patients should utilize external support and/or restrict activities until consolidation occurs¿.

• 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: 15246143
• Report Number: 3006179046-2022-00239
• Device Sequence Number: 5758223
• Product Code: HSB
• UDI-Device Identifier: 00812258020736
• UDI-Public: 812258020736
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 08/31/2022

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: P12.5-80D305
• Device Lot Number: 0112402AAA
• Was Device Available for Evaluation?: No
• 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: 07/24/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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: Male
• Patient Weight: 105 KG