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

Model Number	PS11.5-50D235
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation nor were x-ray films or pictures provided to confirm the alleged event.Root cause is unknown at this time.
Event or Problem Description
Information was received that a stryde nail broke during removal.No patient injury was reported.
Event or Problem Description
Information was received that a stryde nail broke during removal.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: a review of device history records for the returned unit confirmed that it met all required quality inspections and release criteria prior to release.The nail was visually inspected.During visual inspection, the anti-rotation lug was noted to have disengaged from the housing tube.The barbs of the anti-rotation lug had minor damage likely caused from the disengagement which occurred during removal.The nail was unable to be functionally tested due to its condition but coordinate measuring machine inspection of the returned device confirmed the anti-rotation lug barb diameters were within specification.The root cause of the reported event is unable to be determined.

• Brand Name: PRECICE 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: 10377211
• Report Number: 3006179046-2020-00368
• Device Sequence Number: 11463229
• Product Code: HSB
• UDI-Device Identifier: 00887517951236
• UDI-Public: 887517951236
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: PS11.5-50D235
• Device Lot Number: 9043010AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 03/17/2021
• 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: Required Intervention