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

Model Number	P10.7-80B275
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the nail was implanted and was distracted 1mm in the operating room (or) with an electronic remote controller (erc) device and the case was completed in the normal fashion.It was later reported by the surgeon that the erc was not moving the nail.A new erc was provided and the nail was still unable to be distracted.A revision procedure was performed to exchange the nail.The new nail was implanted, tested, and was able to be distracted.
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.
Additional Manufacturer Narrative
The nail was returned to nuvasive for evaluation.Visual inspection revealed no damage to the housing body.X-rays taken of the internal components revealed a "flattened" anti-washer.Sectioning also revealed that the washer pressed against the distraction rod.After sectioning, it was observed that the distraction rod was retracted past the point of engagement with the washer.Additionally the nail was received shorter than it was shipped.The reported issue of being unable to distract was confirmed.Based on the collected information, it is highly likely that the nail failed to distract due to the distraction rod being over retracted.The device history records were reviewed, and found the device was manufactured in accordance with the specified requirements and met all the required quality inspections.There were no discrepancies or non-conformances related to the reported event.
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, INCORPORATED; 101 enterprise ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 18988644
• Report Number: 3006179046-2024-00120
• Device Sequence Number: 19547643
• Product Code: HSB
• UDI-Device Identifier: 00812258020262
• UDI-Public: 812258020262
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10.7-80B275
• Device Lot Number: 4011028
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male