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

Model Number	P8.5-50B215
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the nail was not lengthening.No patient injury was reported.
Additional Manufacturer Narrative
The nail revealed no visible damage but showed it was partially distracted.X-ray images of the internal components revealed a broken coupler/last stage weld.Functional testing revealed the nail was able to retract by hand which approved some damage on the nail internal components.The returned product produced force output of 150 lbs.; which is below the specification of 180 lbs.Stroke test showed no signs of distraction.The root cause of the failure to distract was due to repeat retraction force from improper use of the electronic remote controller (erc) or fast distractor.The erc or the fast distractor may have been held in the incorrect orientation during the implantation procedures /or pre-operative diagnosis, causing the device to be retracted instead of being distracted resulting in a weld failure and leading to the broken coupler.As a part of the investigation, the device history records were reviewed, and no discrepancies were found related to this complaint.The devices were manufactured in accordance with the specified requirements and met all the required quality inspections.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10956418
• Report Number: 3006179046-2020-00494
• Device Sequence Number: 13599143
• Product Code: HSB
• UDI-Device Identifier: 00812258020194
• UDI-Public: 812258020194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P8.5-50B215
• Device Lot Number: 0073012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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: Hospitalization
• Patient Weight: 77