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	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: one (1) device, lot tl5, was received 25/mar/2021.One (1) device, lot bbmg, was received 6/apr/2021.A supplemental vmsr will be submitted upon completion of the remaining seven (7) investigations.
Event or Problem Description
This report summarizes two malfunction events where the tip of a denali thoracic probe "broke" intra-operatively.All pieces were removed from the patient and the procedure was successfully completed with no delay or adverse consequence to the patient.
Event or Problem Description
This report summarizes two malfunction events where the tip of a denali thoracic probe "broke" intra-operatively.All pieces were removed from the patient and the procedure was successfully completed with no delay or adverse consequence to the patient.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Corrected data: previously stated in h.10.That "a supplemental vmsr will be submitted upon completion of the remaining seven (7) investigations"; however, there were only 2 devices captured/reported.Lot tl5 (manufactured 16/jul/2008): visual analysis observed that device tip had fractured between the 30mm and the 40mm laser marking.It was also noted that the laser markings of the device were worn, and discoloration was present throughout the surface of the instrument.Lot bbmg (manufactured 11/apr/2012): visual analysis observed that device tip had fractured near the 10mm laser marking.It was also noted that the laser markings of the device were worn.Manufacturing records reveal that the devices were 9 to 13 years old at the time of event.It is likely that repeated use throughout the device's service life could have compromised the material integrity at the tip, causing the observed fracture.

• 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: 11746170
• Report Number: 3004774118-2021-00127
• Device Sequence Number: 17107771
• 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: 2
• 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): 07/26/2021

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: BBMG, TL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1