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

Model Number	STP4-500
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
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 (b)(6) 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.See also report: 3006179046-2021-00104.
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 2 of 2.

• 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: 11625464
• Report Number: 3006179046-2021-00222
• Device Sequence Number: 3658107
• Product Code: HSB
• UDI-Device Identifier: 00887517952431
• UDI-Public: 887517952431
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• 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: STP4-500
• Device Lot Number: 9011088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial 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