MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

Model Number	PS10.0-80D280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.Radiographs provided did not confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that an osteotomy procedure was performed on (b)(6) 2020.As per the reporter, the nail was not lengthening in the left leg.
Additional Manufacturer Narrative
Device evaluation: the nail was visually inspected and revealed that the housing tube was deformed (dent) and there were laser marks on the nail.X-rays for internal components showed no damage and revealed the nail to be partially distracted.The nail was functionally tested and was not able to distract and retract with the erc and high-speed magnet.It was found to be jammed.It subsequently failed the force test and stoke test.The reported description was confirmed as there was damage found on the housing tube located at the anti-rotation lug and it may have caused excessive drag on the distraction rod which resulted in a failure to distract.The drag from the dent may have caused the inability to apply enough force for limb lengthening.However, the dhr documents indicated that unit was manufactured in accordance with the specified requirements at that time and met all of the required quality inspections prior to shipment.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9901015
• Report Number: 3006179046-2020-00159
• Device Sequence Number: 2807971
• Product Code: HSB
• UDI-Device Identifier: 00887517951199
• UDI-Public: 887517951199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: PS10.0-80D280
• Device Lot Number: 81207312-AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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; Other