MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE BONE TRANSPORT SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

Model Number	BT13-10X400-7
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs provided to confirm the alleged event.Even though root cause cannot be confirmed, information received indicated, surgeon believes that this led in early consolidation.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the nail would not transport any further.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.X-ray images did not indicate any discrepancies.Functionality testing revealed the total stroke measurement was 100.96mm which meets the equal to or greater than 100 mm specification.Retraction force testing was measured at 190lbs which meets the equal to or greater than 180 lb specification.The device met manufacturing specifications.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 10112945
• Report Number: 3006179046-2020-00320
• Device Sequence Number: 14407259
• Product Code: HSB
• UDI-Device Identifier: 00887517977083
• UDI-Public: 887517977083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BT13-10X400-7
• Device Lot Number: 9120218AAA
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: 49 YR