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 Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail lengthened about 3.5cm before it was found to be bent.Although the nail was found to be bent, the patient completed extension.However, the patient is now experiencing pain as the nail is broken after the patient jumped into water.The nail was explanted.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail (lot 2021406aaa) revealed that the unit¿s housing tube has broken at the center 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.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¿.
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: 15129605
• Report Number: 3006179046-2022-00237
• Device Sequence Number: 15104055
• Product Code: HSB
• UDI-Device Identifier: 00812258020583
• UDI-Public: 812258020583
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 2021406AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 56 KG