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

Model Number	P8.5-50D215
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
Information was received that the patient prematurely consolidated and another osteotomy was performed.The nail was reported to have failed to distract intra-operatively.No patient adverse event was reported.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product showed no visible damages on the nail.X-ray images of the internal components showed no damage and revealed the nail was distracted just beyond the midpoint.The nail was functionally tested and was unable to be distracted and retracted with the external remote controller (erc) or the high-speed magnet which confirmed the reported failure.The nail was found to be totally jammed.Upon dismantling the device, dry blood build up was found on the distraction rod.No other issue was found with the internal components.There was insufficient information provided to be able to determine a root cause; however, the implant may have been damaged when testing on the back table and/or its reuse after being implanted as this is a single use device.
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: 14137645
• Report Number: 3006179046-2022-00179
• Device Sequence Number: 11835631
• Product Code: HSB
• UDI-Device Identifier: 00812258020583
• UDI-Public: 812258020583
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2022

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: P8.5-50D215
• Device Lot Number: 1031909
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 04/20/2022; 06/29/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 04/20/2022; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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 Sex: Prefer Not To Disclose