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

Model Number	P12.5-80D305
Medical Device Problem Codes	Collapse (1099); Crack (1135)
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 patient had finished lengthening and was in the consolidation phase when the crown cracked and the nail collapsed.No patient adverse event was reported.
Additional Manufacturer Narrative
Device has not been returned for evaluation; however device return is anticipated.No conclusions can be drawn at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
Visual inspection of the returned nail revealed, that the housing tube had cracks at the anti-rotation lug and the crown region.Based on visual inspection, the reported failure was confirmed.The x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The iqc inspection data for the lots of anti-rotation lug and housing tube was reviewed and confirmed the parts met design specifications, per the engineering drawings.The work order was reviewed and confirmed, the device passed all inspections per the acceptance tests.The anti-rotation lug being cracked, indicates the type of breakage that can be a result of excess stress (torsional force) that is applied to the nail as a result of the patient¿s daily activities.
Event or Problem Description
No additional information was 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: 13545962
• Report Number: 3006179046-2022-00124
• Device Sequence Number: 14712168
• Product Code: HSB
• UDI-Device Identifier: 00812258020736
• UDI-Public: 812258020736
• 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: 2021
• 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
• Report Date (Section B): 03/14/2022

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: P12.5-80D305
• Device Lot Number: A171126-02-1AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2017
• 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: Male