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

Model Number	P12.5-80A245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Metal Related Pathology (4530)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the patient was found to have hypertrophic non-union.The non-union was treated with lavage, refresh cuts, iliac grafting and osteosynthesis.The patient was reported to have also had metallosis and the working components of the nail were noted to be exposed with grease.The metallosis was not concluded via lab analysis as it was described to be related to the reported grease the nail was reported to have been implanted for longer than the recommended timeframe and during the removal procedure it was found to be broken.The patient was noted to have been weightbearing.There was no patient history of trauma or accidents.No additional information has been provided.
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.
Additional Manufacturer Narrative
There were no issues found during the review of production records; there is no correction or remedial action necessary.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, d4 (lot number), d9, h3, h4, h6 (type of investigation), h10.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the nail has been returned to nuvasive for evaluation.Upon receipt, the device was examined and found to be exhibiting bending along two points, a fractured housing tube at the distraction end, and the absence of the anti-rotation lug.Additionally, cross-threading was noted at the threaded end, and the distraction rod displayed unrestricted spinning and pistoning.Visible staining was evident throughout the housing tube surface.Device x-rays of the internal components revealed gear train separation, leaving a sun and planet component within the housing tube, with two such components still attached to the distraction rod.Examination indicated a slipped thrust bearing ferrule and retainer.Review of production x-rays uncovered weak contact between one of the devices in this lot and the housing tube with retainer grooves.As the device was found to be broken and non-functional, functional testing was unable to be executed.Photographic evidence from the visual inspection substantiates the presence of discolored lubricant.It should be noted that the implantation time was approximately 4 years, significantly above the recommend implantation time per the precice instructions for use (ifu).In conclusion, all component and device damage, including the discolored krytox (lubricant), is consistent with patient weight bearing.Additionally, the provided patient x-rays and device photos were reviewed and confirmed the following: the device has black material on it.Plain anterior-posterior radiograph of the left femur indicates there is an atrophic nonunion of the distal femur at the level of the metaphysis-diaphysis junction.The nail appears to be slightly bent at the level of the femoral nonunion.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 specifications prior to shipment.Device labeling: per the precice ifu, the "device should be removed after implantation time of no more than one year".
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: 18257732
• Report Number: 3006179046-2023-00357
• Device Sequence Number: 14473877
• Product Code: HSB
• UDI-Device Identifier: 00812258020149
• UDI-Public: 812258020149
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 01/31/2024

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: P12.5-80A245
• Device Lot Number: 9111305AAA
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 01/23/2024; 01/30/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/22/2023; 01/25/2024; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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: Male