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

Catalog Number	101-90197
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
It was reported that during pedicle preparation, the tip of a denali straight thoracic probe broke intra-operatively.Surgery was successfully completed with a 10 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The sales representative stated that the probe fractured during a plif procedure and that the patient's bone was hard and sclerotic.A 2015 capa determined that probe tip fractures were consistent with excessive force, as thoracic probes are often used in the lumbar and sacral areas of the spine.However, since lot number is unknown, it cannot be determined whether the device falls under the scope of the capa.Since the device is not available, an exact cause could not be determined.Potential causes include: excess impaction force applied or normal wear due to extensive use or device age.H3 other text : device was discarded.
Event or Problem Description
It was reported that during pedicle preparation, the tip of a denali straight thoracic probe broke intra-operatively.Surgery was successfully completed with a 10 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: SPECIAL, STRAIGHT THORACIC PROBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10524658
• Report Number: 3004774118-2020-00210
• Device Sequence Number: 16932828
• Product Code: LXH
• UDI-Device Identifier: 10888857010499
• UDI-Public: 10888857010499
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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 Catalogue Number: 101-90197
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1