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

Model Number	P12.5-80D275
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the implant failed before reaching the extension target.As per the surgeon, the patient did not follow weight bearing instructions and put too much weight on the nail.No patient adverse event was reported.
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
No additional information was provided.
Additional Manufacturer Narrative
The device was not returned to nuvasive for investigation.However, x-ray images were provided and during evaluation of the provided x-ray images, an intramedullary nail with 2 proximal and 2 distal locking screws was visible.The second proximal locking screw (the more distal of the two) was slightly bent.In addition, the x-ray images revealed the al-br nut was partially backed out from the distraction rod.However, as the nut was only partially backed out (not fully backed out), this indicates the distraction rod was still engaged with the lead screw and also indicates reported issue was not related to the al-br nut backing out from the distraction rod (note: the manufacturing x-ray image showed the al-br nut was seated properly in the distraction rod).There were no additional device-related abnormalities or issues noted.Without the return of the device, visual and functional testing could not be performed to determine a definitive root cause for the reported issue or the backed out al-br nut.However, based on the complaint description and the bend in the second proximal locking screw, a possible root cause for these issues is related to the reported excessive stress/force applied to the nail as a result of patient not following weight bearing instructions/limitations.Device history review: the device history records (dhr) were reviewed and confirmed the device met all quality inspections and specifications prior to release.

• 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: 13958642
• Report Number: 3006179046-2022-00164
• Device Sequence Number: 17230920
• Product Code: HSB
• UDI-Device Identifier: 00812258020729
• UDI-Public: 812258020729
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: A180122-04-1AB
• Was Device Available for Evaluation?: No
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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
• Patient Sex: Male
• Patient Weight: 130 KG