MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS PRECICE STRYDE; INTRAMEDULLARY FIXATION ROD

Model Number	PS10.0-80SJ305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Debris, Bone Shedding (1803)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor radiographs were provided to confirm the alleged event.
Event or Problem Description
Information was received that patient was experiencing pain, and the nail was removed.A bone void was found in the same area on the medial cortex.No patient injury reported.
Additional Manufacturer Narrative
The precice stryde was received for functional and visual testing and the reported event was not confirmed.The returned precice stryde was observed and no damage was found.Based on this investigation, the failure mode could not be confirmed.The root cause of the reported event was not identified.A review of dhr for the returned unit confirmed that it met all the required quality inspections (x-ray inspection and acceptance test).

• Brand Name: PRECICE STRYDE
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr; aliso viejo CA 92656
• MDR Report Key: 10171997
• Report Number: 3006179046-2020-00335
• Device Sequence Number: 2142887
• Product Code: HSB
• UDI-Device Identifier: 00887517951625
• UDI-Public: 887517951625
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: PS10.0-80SJ305
• Device Lot Number: 9070910AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: 16 YR
• Patient Weight: 50