MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS VERTECOR®; DRILL BIT

Catalog Number	2224/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a procedure a bone drill tip detached within the patient's spine.The tip was eventually encapsulated and was not protruding or causing patient discomfort.The foreign body is still within the patient's spine, there are no plans to explant the foreign body."nothe" account alleges that during a procedure a bone drill tip detached within the patient's spine.The tip was eventually encapsulated and was not protruding or causing patient discomfort.The foreign body is still within the patient's spine, there are no plans to explant the foreign body.No chance of migration, or injury.Patient doing well and physician i snot interested in intervention.The patient age was taken into consideration.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A photograph was also provided by the account.The device was examined visually and microscopically.The complaint is confirmed.Information received from the field indicate that the root cause is attributed to rough handling.The device was struck with a mallet during use, the device was used contrary to ifu.The failure mode was updated to use error.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number have been identified.

• Brand Name: VERTECOR®
• Common Device Name: DRILL BIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12747434
• Report Number: 9616662-2021-00013
• Device Sequence Number: 11898792
• Product Code: HTW
• UDI-Device Identifier: 00884450296325
• UDI-Public: 884450296325
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2021

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 2224/A
• Device Lot Number: BDR-2102-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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: Unknown