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
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.
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
Device evaluation: visual inspection of the returned nail revealed no external damage.X-ray images of the internal components showed no damage and revealed the nail was partially distracted.The nail has been functionally tested and was able to be distracted and retracted with the high-speed magnet tool as well as with an external remote controller (erc) 1.The length as received measured at 313.05mm.The minimum and maximum lengths were measured and meets the specification.Distraction force testing has been measured and meets the specification.With the limited information provided and the testing performed upon return, the reported failure mode could not be confirmed.The nail was found to meet specifications.The alleged deficiencies could not be confirmed or duplicated.Device records review: review of the device history records indicates that the unit met all required quality specifications and testing prior to product departure.
Event or Problem Description
It was reported that the nail did not extend and was 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: 16196538
• Report Number: 3006179046-2023-00106
• Device Sequence Number: 14945129
• Product Code: HSB
• UDI-Device Identifier: 00812258020347
• UDI-Public: 812258020347
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 2032105AAA
• 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: 02/07/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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