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

Model Number	P12.5-80B275
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that while testing during implantation the nail failed to distract after multiple attempts to lengthen intra-operatively.The procedure was completed using a new nail.The nail was examined after the procedure and the male/female junction was reportedly never securely fastened together allowing the nail to be pulled apart with little to no effort.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product revealed no external damage.The nail was determined to have been partially distracted.The nail's initial length was measured at 301.12 mm; further investigative inspection of the returned nail revealed the distraction rod was functionally lengthening by hand which would likely indicate a broken internal component.The reported event is therefore confirmed as the distraction rod was loose; this is usually referred to as "pistoning" which would indicate a retention failure.The x-ray images of the internal components taken upon return revealed the thrust bearing and planets have been found to be loose in the housing tube as well as disengaged from the housing tube.The inspection data for the lots of the thrust bearing and planets as well as the housing tube have been reviewed and confirm the parts met design specifications per the engineering drawings.The cause for the disengagement of the thrust bearing and planets from the housing body cannot be identified at this time.Device records review: review of the device history records indicates the unit met all quality specifications and testing prior to product departure per the work order.

• 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: 16234734
• Report Number: 3006179046-2023-00107
• Device Sequence Number: 17860196
• Product Code: HSB
• UDI-Device Identifier: 00812258020330
• UDI-Public: 812258020330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/30/2023

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: P12.5-80B275
• Device Lot Number: 2111803AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 79 KG