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

Model Number	P12.5-80D275
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned nail revealed no external damage.X-ray images of the internal components showed no damage and revealed the nail had been fully retracted.The nail was functionally tested and distraction and retraction were successful with the high-speed magnet tool and the external remote controller (erc).The length as received was measured at 274.34 mm.The maximum and minimum lengths were measured at 355.99 mm and 274.48 mm, respectively, giving a total stroke measurement of 81.51 mm which meets the specification.Distraction force testing was measured at 300 lbs which meets specification.With the limited information provided, the reported failure mode could not be confirmed as the nail was found to be fully functional and met all specifications.Device records review: review of the device history records (dhr) indicated the unit met all required quality specifications and testing prior to product departure.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that after being implanted the nail would not distract when the surgeon attempted to lengthen intra-operatively to ensure functionality.The surgeon opted to swap out the non-functioning nail with another nail and the procedure was successfully completed.There was no patient injury reported.

• 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: 15933183
• Report Number: 3006179046-2022-00280
• Device Sequence Number: 11876956
• Product Code: HSB
• UDI-Device Identifier: 00812258020729
• UDI-Public: 812258020729
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/07/2022

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: P12.5-80D275
• Device Lot Number: 1091612AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• 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: 11/15/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 22 YR
• Patient Sex: Male
• Patient Weight: 79 KG