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

Model Number	P8.5-50C195
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nail will not be returning for device evaluation and the surgeon opted to leave the anti rotation lug in the patient.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
It was reported that the nail was removed because the scheduled length had been achieved.A crack in the nail was not noticed until it was out of the patient and on the back table.X-ray images revealed "a screw" still in tibial canal.After examining the nail, the anti-rotation lug was not in the nail but in the patient.
Additional Manufacturer Narrative
Correction: h6 (health effect - impact code).Additional data: h3, h6, h10.The nail was not returned for investigation.However, photos and x-rays were provided.Review of photos noted a cracked housing tube and review of the provided x-ray images observed that the anti-rotation lug was disengaged from the housing tube, and the anti-rotation lug was stuck to the tibia canal.A definitive cause of the reported issues could not be determined due to no device return; however, based on photo and x-ray review, it can be deduced that due to the crack in the housing tube, the mating between the tube and anti-rotation lug may have become loose.Then, during the normal operation of the nail, the torsional forces applied to the lug may have caused the lug to disassociate from the housing tube.Based on similar complaints in the past, the cracking in the housing tube is caused by excessive bending stress applied to the nail due to weight applied during patient activities.It should also be noted the device remained implanted for approximately 2.5 years (per ifu, the device should not remain implanted for greater than one year).The production inspection data for the lots of anti-rotation lug and housing tube were reviewed and confirmed the parts met design specifications per the engineering drawings.Review of the device history records indicated the unit met all quality specifications and testing prior to product 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; 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: 13695206
• Report Number: 3006179046-2022-00139
• Device Sequence Number: 19254589
• Product Code: HSB
• UDI-Device Identifier: 00812258020378
• UDI-Public: 812258020378
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 04/06/2022

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: P8.5-50C195
• Device Lot Number: 9071903AAA
• Was Device Available for Evaluation?: No
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 51 KG