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

Model Number	P12.5-80B305
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted following the device evaluation.
Event or Problem Description
It was reported that the female part of the male/female junction broke on the nail.No patient adverse event was reported.The patient received a new nail with no complications and is continuing his lengthening sessions.
Additional Manufacturer Narrative
Visual inspection of the returned nail revealed the housing tube had cracks at the anti-rotation lug or the crown region.Based on visual inspection, the reported failure was confirmed.In addition, x-ray images of internal components revealed an al-br nut backed out from the distraction rod.The nail was functionally tested and was able to be distracted and retracted with the external remote controller (erc) and high-speed magnet.Distraction force testing was measured at 262.58 lbs, which meets the =180lb specification.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) and the al-br nut were seated properly in the housing body and distraction rod.Specific information was not provided or known event advised that may have occurred which could be linked to the crack on the housing tube.However, based on the type of breakage observed during investigation, it is possible that the nail broke due to stress generated from weight-bearing activities.Per the precice instructions for use: "the precice nail cannot withstand the stresses of full weight bearing.Patients should use external support, and/or restrict activities as directed by the physician until consolidation occurs." also, the al-br nut bonding failure is a previously known issue which is being investigated.A review of dhr indicates no ncmrs or deviations associated with the work order and that all units met the required quality inspections (x-ray inspection and acceptance test) prior to shipment.
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; 101 enterprise #100; aliso viejo 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13694771
• Report Number: 3006179046-2022-00138
• Device Sequence Number: 5009166
• Product Code: HSB
• UDI-Device Identifier: 00812258020347
• UDI-Public: 812258020347
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: P12.5-80B305
• Device Lot Number: 1021807AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 79 KG