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	11/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported that during lumbar spine correction, the denali spinal system thoracic probe tip fractured while drilling the pilot hole at left l5 intra-operatively.The tip was retrieved immediately from the surgical site.The procedure was completed successfully with another thoracic probe without surgical delay.
Additional Manufacturer Narrative
Visual inspection: it was observed that device tip had been fractured, near the 40mm laser marking.It was also noted that the laser markings of the device were worn.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Manufacturing records reveal that the device was about 10 years old at the time of event, as it was manufactured in 2010.It is likely that repeated use during the device's service life could have compromised the material integrity of the device, causing the observed fracture.
Event or Problem Description
The physician reported that during lumbar spine correction, the denali spinal system thoracic probe tip fractured while drilling the pilot hole at left l5 intra-operatively.The tip was retrieved immediately from the surgical site.The procedure was completed successfully with another thoracic probe without surgical delay.

• 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: 11005679
• Report Number: 3004774118-2020-00346
• Device Sequence Number: 11886101
• Product Code: LXH
• UDI-Device Identifier: 10888857009868
• UDI-Public: 10888857009868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: AEXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1