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

Model Number	P8.5-80C245
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during treatment the nail unwound and shortened.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail revealed no external damage.The x-ray images taken upon return did not indicate any damage to the internal components and they revealed the nail had been partially distracted.The nail was functionally tested and was distracted and retracted with the high-speed magnet tool as well as with an external remote controller (erc).The length as received measured at 278.21mm.The minimum, and maximum length were measured at 244.18 mm and 326.05 mm, respectively, giving a total stroke measurement of 81.87mm which meets the specification.The distraction force testing was measured and met the specification.The nail has been determined to meet specifications.The complaint investigation and functional testing were unable to confirm or duplicate the alleged deficiency with this device.No objective evidence has been provided to confirm the reported loss of distraction.Despite multiple attempts to follow up with the complaint reporter, no additional information such as pictures or x-ray images have been provided to assist in clarifying the reported deficiency to support the complaint description of the nail shortening.Device record review: review of the device history records (dhr) indicates that the unit met all required quality specifications and testing prior to product departure.
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: 16708116
• Report Number: 3006179046-2023-00159
• Device Sequence Number: 3585076
• Product Code: HSB
• UDI-Device Identifier: 00812258020408
• UDI-Public: 812258020408
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: P8.5-80C245
• Device Lot Number: 2021802AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female