MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD CAVITY CREATION.DFINE®.POWERCURVE; NAVIGATING OSTEOTOME

Model Number	00884450296523
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a vertebral augmentation [kyphoplasty] post-procedure, the tip of the navigating osteotome detached within the patient's vertebral body.The first level augmentation was successful.During the second level augmentation the physician noticed that the osteotome would not articulate.After a few minutes of manipulation, the device was successfully removed however, the physician noted that the tip had detached within the patient.The tip was not retrieved from the patient's vertebral body.Fluoroscopy demonstrated that the broken tip was wedged within a vertebral pedicle.The physician did not want to attempt a pedicle plasty.The patient was discharged without additional consequences.The physician will continue to monitor.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to use error.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: CAVITY CREATION.DFINE®.POWERCURVE
• Common Device Name: NAVIGATING OSTEOTOME
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• MDR Report Key: 9799476
• Report Number: 9616662-2020-00003
• Device Sequence Number: 14307438
• Product Code: LXH
• UDI-Device Identifier: 00884450296523
• UDI-Public: 00884450296523
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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 Expiration Date: 08/31/2022
• Device Model Number: 00884450296523
• Device Catalogue Number: PWR-2011L/A
• Device Lot Number: PWL-1708-28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1