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

Model Number	PS11.5-50B235
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact event/explant date is unknown but reported to be in (b)(6) 2021.The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any relevant additional information has been provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail separated at the junction during an explantation procedure.No patient adverse event was reported.No additional information is available.
Additional Manufacturer Narrative
Corrected additional data.
Event or Problem Description
Additional information was provided.
Event or Problem Description
No new information was provided.
Additional Manufacturer Narrative
Device evaluation: the returned nail was observed and the anti-rotation lug was disengaged from the housing tube which confirmed the reported failure.The barbs of the anti-rotation lug and the anti-rotation feature on the inside of the housing tube had some damage, likely from the disengagement which occurred during the removal of the device.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The device was properly manufactured and inspected per the work order.The probable root cause for the disengagement of the anti-rotation lug from the housing body is due the high forces acting on the nail during explantation.It should also be noted that the explantation of the nail was performed after its expiration date.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.

• Brand Name: PRECICE STRYDE SYSTEM
• 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: 11785633
• Report Number: 3006179046-2021-00270
• Device Sequence Number: 3909444
• Product Code: HSB
• UDI-Device Identifier: 00887517950819
• UDI-Public: 887517950819
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2021

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: PS11.5-50B235
• Device Lot Number: 9012910AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 07/19/2021; 10/22/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/19/2021; 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1