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

Model Number	P10.7-50U190
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause is unable to be confirmed at this time.If any additional information is received, a supplemental report will be submitted.
Event or Problem Description
Information was received that during a plate assisted bone segment transport procedure, the nail would not distract upon attempting to recharge.The surgeon attempted to engage the nail, but ended up removing it and completing the procedure using a new nail.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail did not reveal any visible external damage to the device.It was, however, noted that the nail was received in a fully distracted state, despite the reported event of an inability to distract.An x-ray analysis was performed for the nail¿s internal components which verified that the nail was fully distracted on the tapered lead screw.No other component abnormalities/discrepancies were found during review of the x-ray.Functional testing was performed and the nail was able to be both fully retracted and distracted.Force testing was performed and passed acceptance criteria.Thus, no failure to distract/retract could be confirmed.Device labeling: it was reported that the alleged issue occurred while the surgeon was attempting to ¿recharge¿ and reuse the nail, however, the nail is a single use device per the precice instructions for use (ifu) and it is not intended to be ¿recharged¿ or reused.Device record review: a review of the device history record (dhr) confirmed the device met all quality inspections and specifications prior to release.
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, 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: 17052849
• Report Number: 3006179046-2023-00268
• Device Sequence Number: 7067377
• Product Code: HSB
• UDI-Device Identifier: 00812258026264
• UDI-Public: 812258026264
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: P10.7-50U190
• Device Lot Number: 2101705BAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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: Female
• Patient Weight: 73 KG