MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P10.7-80B245
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been returned for evaluation and no additional information has been provided.The root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed due to the rod failing to distract after one week of lengthening.After removal, the nail was tested with a fast distractor by the surgeon, and it was reported not to be distracting.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Implant lot number 4012301aaa (model p10.7-80b245) was received for in-house evaluation.The nail was decontaminated, however, it was decided to not proceed with metricide soak or enzymatic solution sonicator as it was not needed.The returned device measured to be 248.59mm upon receival.The fast distractor was able to activate the mechanism and distract/compress.The device was then placed into the force test fixture and the nail was observed to distract correctly up to the limit of the fixture (172 lbf).Additionally, the device was confirmed to extend using the fast distractor.X-ray image of the device did not show any broken or misaligned internal components.X-rays are attached.It is unknown exactly what caused the lack of distraction in the operating room (or) since the failure could not be duplicated.Due to these findings, the complaint is unable to be confirmed as the device functioned as intended.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 20248908
• Report Number: 3006179046-2024-00175
• Device Sequence Number: 12587951
• Product Code: HSB
• UDI-Device Identifier: 00812258020255
• UDI-Public: 812258020255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: P10.7-80B245
• Device Lot Number: 4012301AAA
• Was Device Available for Evaluation?: Yes
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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 Sex: Unknown