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); Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/17/2022
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
It was reported that the nail did not extend and was replaced with a new one.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Updated section h6 investigation findings and investigation conclusions investigation from the capa identified a potential reason for the disengaged ai-br nut is due to application technique that affects the performance of the epoxy bond interface strength, coupled with added weight while distracting.This caused all but the control nail to fail.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned precice nail revealed there was no visible damage.The x-ray images of the internal components revealed that the al-br nut backed out from the distraction rod and the thrust bearing was determined to be broken which is visible and may have caused the nail to stop lengthening.The reported failure has, therefore, been confirmed.The nail was functionally tested and it was determined that the distraction rod within the nail was able to be lengthened by hand which would likely point to a al-br failure.The force test and stroke test showed no signs of distraction or retraction (likely due to the al-br nut bonding failure/broken bearing).During sectioning of the nail it was observed that the al-br nut was out of the distraction rod.Upon review of the x-ray images on the released work order, there were no disparities or anomalies seen.During review of the inspection quality control (iqc) data for the lots of housing tube, distraction rod, and thrust bearing confirmed that the parts met design specifications per the engineering drawings.Review of the work order indicates the device passed all inspections per the acceptance tests.The al-br nut bonding failure is a known event/issue which is being investigated under a corrective and preventative action.Based on feedback from the healthcare provider/patient, no event in particular has occurred in which they believe may have contributed to or led to the nail failure.There was no exact cause known for the broken thrust bearing.Although, based on the provided information it would appear likely the nail became damaged when the surgeon attempted to recharge the nail on the back table during the revision procedure.Device labeling: per precice intramedullary limb lengthening system instructions for use, "this product is licensed to the customer for single use only." device records review: the review of the device history records (dhr) indicated the unit met all required quality specifications and testing prior to product departure.
Event or Problem Description
It was reported that the nail only extended 7.1cm and stopped.The nail was reportedly loose and moving inside and has now been explanted and replaced with a new one.

• 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: 16196533
• Report Number: 3006179046-2023-00105
• Device Sequence Number: 20326277
• Product Code: HSB
• UDI-Device Identifier: 00812258020347
• UDI-Public: 812258020347
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/20/2023

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: 2081903AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Supplement Date Received by Manufacturer: 02/13/2023; 02/13/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/20/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 70 KG