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

Model Number	P8.5-50D215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail revealed the housing tube was broken at the anti-rotation lug or the crown region which confirmed the reported failure.The work order was reviewed and confirmed the device passed all quality inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The inspection data for the lots of anti-rotation lug and housing tube were reviewed and confirmed the parts met design specifications per the engineering drawings.Based on limited information provided with regard to the patient impacts and no specific details the likely cause of the failure is unable to be determined, however, based on the type of breakage observed it is possible the nail broke due to stress generated from weight bearing activities.Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.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".If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that during a planned removal procedure the nail was found to be cracked in the distal aspect of the outer housing.The crack on the nail was noted to extend proximal another 2-4cm.The patient reported no falls, impacts, pain, or other notable events that would contribute to the breakage.A piece of the housing was missing from the nail and was left inside the patient's medullary canal.The surgeon attempted to retrieve the remaining metal piece in the medullary canal, but decided to proceed with inserting the new trauma nail without successfully removing the broken piece.

• 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 drive; suite 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 16273137
• Report Number: 3006179046-2023-00108
• Device Sequence Number: 7492273
• Product Code: HSB
• UDI-Device Identifier: 00812258020583
• UDI-Public: 812258020583
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: P8.5-50D215
• Device Lot Number: 0031001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• 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: 01/12/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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
• Patient Sex: Female