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

Model Number	PS10.0-80D335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that upon extraction of the nail, the proximal end of the nail broke away at the screw hole leaving the distal portion of the nail in the patient's femur.The surgeon had to enter the distal side of the patient femur, opening the patient up above the knee to push the distal portion of the nail through to complete the extraction process which resulted in a 5 hour surgery.It was additionally reported that the patient has suffered a fracture of the femur due to the intervention required to remove the nail following the breakage.No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the device was received in two pieces.Visual inspection verified that the device was broken through the screw holes on the proximal end.Further investigation reflected the anti-rotation lug was pulled out of position.The reported bone fracture was unable to be verified as no objective evidence was provided.In-house device x-ray reflected the anti-rotation lug was damaged, likely during the extraction procedure.Functional testing was attempted and the device was unable to distract using the fast distractor, distraction fixture, or a test external remote controller (erc) unit.This implant is indicated for a one year implantation time per the instructions for use (ifu) current at the time of implantation.Therefore, it is likely that the combination of the extended implantation time and the resulting difficult removal resulted in the implant being placed under more force than it was designed for leading to a fracture of the housing body.Device labeling: "device should be removed after implantation time of no more than one year".
Event or Problem Description
No additional information has been provided.
Event or Problem Description
Additional information was received clarifying that the nail was broken prior to extraction.
Additional Manufacturer Narrative
Additional/corrected device evaluation: the device was received in two pieces.Visual inspection verified that the device was fractured through the screw holes on the proximal end.Further investigation reflected the anti-rotation lug was pulled out of position.The exposed surface of the anti-rotation lug showed some deterioration; most likely from the exposure to the patient¿s internal environment.The reported bone fracture was unable to be verified as no objective evidence was provided.In-house device x-ray reflected the anti-rotation lug was damaged, likely during the extraction procedure.Functional testing was attempted and the device was unable to distract using the fast distractor, distraction fixture, or a test external remote controller (erc) unit.This implant is indicated for a one year implantation time per the instructions for use (ifu) current at the time of implantation.Therefore, while the root cause of the fracture cannot be definitively determined, based off of the implantation length and the location of the fracture, it is possible that the extended implantation time and/or patient factors may have contributed to the fracture.

• Brand Name: PRECICE STRYDE 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: 17662512
• Report Number: 3006179046-2023-00335
• Device Sequence Number: 7068322
• Product Code: HSB
• UDI-Device Identifier: 00887517951212
• UDI-Public: 887517951212
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: PS10.0-80D335
• Device Lot Number: 8110911AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 11/03/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/02/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2018
• 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: Required Intervention
• Patient Sex: Female