MAUDE Adverse Event Report: K2M, INC. THORACIC PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	101-90054
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of investigation.
Event or Problem Description
This report summarizes one malfunction event where a denali thoracic probe fractured intra-operatively.The procedure was successfully completed with no delay or adverse consequence to the patient.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
This report summarizes one malfunction event where a denali thoracic probe fractured intra-operatively.The procedure was successfully completed with no delay or adverse consequence to the patient.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.H.3.Has been corrected to reflect that the device was not returned as anticipated.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.As the device was not available for evaluation, the failure mode could not be confirmed, and a root cause could not be established conclusively.Correspondence with rep indicates that the device has been in use for over three years.It is possible that repeated use of the device throughout its service life compromised the material integrity, contributing to the reported fracture.H3 other text : device was not returned.

• Brand Name: THORACIC PROBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11247523
• Report Number: 3004774118-2021-00019
• Device Sequence Number: 19745019
• Product Code: LXH
• UDI-Device Identifier: 10888857009868
• UDI-Public: 10888857009868
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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 Catalogue Number: 101-90054
• Device Lot Number: EPCD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1