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	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays or ultrasound images provided to confirm the alleged event.It is unknown if patient complied with post-operative physical restrictions.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the bone transport nail was not distracting.No patient injury was reported.
Event or Problem Description
B.5: see updated information in h2, h3, h6 and h10.
Additional Manufacturer Narrative
The customer¿s report that the bone transport nail was not distracting was not confirmed based on visual inspection and functional testing.As part of the investigation the entire manufacturing process was reviewed.What was discovered was the shimming fixture during testing was missing a component.Due to the missing component, this resulted in an insufficient amount of axial space for the internal components.This is a manufacturing issue and is being addressed in an internal investigation.

• 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: 10003634
• Report Number: 3006179046-2020-00293
• Device Sequence Number: 16842680
• Product Code: HSB
• UDI-Device Identifier: 00887517977083
• UDI-Public: 887517977083
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K182170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: BT13-10X400-7
• Device Lot Number: 9121632AAA
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR