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

Model Number	BT115-80SJ320-7
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that x-rays showed a crack just distal to the transport screw that is at the end of the distal slot.During the explant procedure the nail broke where the defect was visible and was difficult to remove.No further adverse events have been reported.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: review of the provided x-ray images of the nail show a crack on the housing tube prior to removal.Visual inspection of the returned product showed that the housing tube was broken into two pieces which confirmed the reported description.Based on the provided x-ray and the returned product, the observed crack on the housing tube came to a fracture due to the applied forces as the nail was unable to tolerate the force from the removal procedure.The root cause of the crack observed on the housing tube is unable to be determined.However previous investigations revealed that mechanical bending and damage occur due to fatigue when excess stressed is applied to the nail by the patient during daily activities.Device history records review: review of the device history records indicated that the unit met all quality specifications and testing prior to product departure.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 14775462
• Report Number: 3006179046-2022-00208
• Device Sequence Number: 16481239
• Product Code: HSB
• UDI-Device Identifier: 00887517978240
• UDI-Public: 887517978240
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: BT115-80SJ320-7
• Device Lot Number: 9121628AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female