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

Model Number	P8.5-50N150
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a revision procedure was performed as the nail was not lengthening.The nail has been explanted.
Additional Manufacturer Narrative
Visual inspection showed no visible damage, and the nail was fully retracted.The x-ray images taken of internal components revealed a damaged spring stop, 8.5mm (lot 220427-01).Post manufacturing x-ray images within the released work order were also verified, and there were no signs of spring stop failure.The nail was functionally tested, and was unable to distract and retract with the external remote controller (erc) and high-speed magnet.The force test and stroke test showed no signs of distraction (it appears the nail is likely totally jammed.) as part of the investigation, the device history records (dhr) were reviewed and indicated the length of the nail was 147.38 mm at the time of manufacture.The difference between the measurement of the nail at time of manufacture and return was 0.36 mm.The shorter length measured/noted at the time of complaint investigation would indicate that the nail had been retracted.The nail was determined to be possibly jammed due to repeated retraction force from possible improper use of the erc/fast distractor.The erc/fast distractor unit may have been held in the incorrect orientation during the inspection / at the treatment sessions, causing the device to be retracted rather than the required distraction prescription.A review of the dhr documents indicated the nail was manufactured by the specified requirements at that time and met all the required quality inspections before shipment.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise, suite 100; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 15486687
• Report Number: 3006179046-2022-00253
• Device Sequence Number: 18114742
• Product Code: HSB
• UDI-Device Identifier: 00812258028251
• UDI-Public: 812258028251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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: P8.5-50N150
• Device Lot Number: 2061307AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• 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: 09/22/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 50 KG