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

Model Number	P10.7-80D305
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause cannot be confirmed at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that during explantation the nail disassociated and the crown came off.All fragments of the nail were explanted and the patient outcome was successful.
Additional Manufacturer Narrative
Device evaluation: the returned device was inspected and the anti-rotation lug was found to be disengaged from the housing tube which confirmed the reported failure mode.The barbs of the anti-rotation lug had noted damage likely from the disengagement which occurred during the removal of the device.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) was seated properly in the housing body.Based on the provided information, the damage to the nail most likely occurred during the removal procedure as the patient was able to complete lengthening treatments.The nail experienced excessive torsional force during the removal procedure.Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
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: 14137683
• Report Number: 3006179046-2022-00180
• Device Sequence Number: 19869117
• Product Code: HSB
• UDI-Device Identifier: 00812258020668
• UDI-Public: 812258020668
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: P10.7-80D305
• Device Lot Number: 0102910AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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 Age: 18 YR
• Patient Sex: Male
• Patient Weight: 68 KG