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

Model Number	STP4-400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending device evaluation.Root cause cannot be confirmed at this time.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the screw is broken.The nail is locked with 2 screws on lateral and 1 screw on anteroposterior.Extension was completed.No problem occurred during or after extension.During medical controls, delay on bone union was detected.
Event or Problem Description
Information was received that a revision procedure was performed in (b)(6) 2020 due to a broken screw.It was reported that lengthening was completed and no problems occurred during or after lengthening; however, a delay in bone union occurred.The screw was replaced with no further patient impact reported.Report 1 of 2.
Additional Manufacturer Narrative
Device records review: review of the device history record for the returned unit confirmed that it met all required quality inspection criteria prior to release.Device evaluation: visual inspection of the screw revealed it was broken.Dimensional testing was performed and was found to be within specifications.The maximum patient weight for a 10mm nail diameter is 150lbs/69kg which is stated in the instructions for use on page 2.The patient¿s weight was 176.5lbs/80kg which exceeds the maximum weight of 150lbs/69kg.The cause of the event is attributed to an incorrect nail size being used for the patient.

• Brand Name: PRECICE SCREWS
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11131840
• Report Number: 3006179046-2021-00104
• Device Sequence Number: 17184387
• Product Code: HSB
• UDI-Device Identifier: 00887517952394
• UDI-Public: 887517952394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: STP4-400
• Device Lot Number: 9011084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 33 YR
• Patient Weight: 80