MAUDE Adverse Event Report: K2M, INC. CURVED THORACIC PROBE, W/SILICONE HANDLE; SIZE 2.0"; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	101-90295
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
Event or Problem Description
It was reported that the tip of a denali curved thoracic probe fractured off during intra-operative screw hole preparation.The procedure was completed successfully without surgical delay using an alternative instrument.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: it was observed that the device had fractured at its tip.The fragment was not returned with the device.Worn laser markings were also seen.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Review of manufacturing records reveal that the device was about nine years old at the time of event.Repeated use of the instrument throughout its service life could have compromised the material integrity at the probe tip, resulting in fracture.The cause of the reported event will be classified as normal wear.
Event or Problem Description
It was reported that the tip of a denali curved thoracic probe fractured off during intra-operative screw hole preparation.The procedure was completed successfully without surgical delay using an alternative instrument.No adverse consequences or medical intervention were reported.

• Brand Name: CURVED THORACIC PROBE, W/SILICONE HANDLE; SIZE 2.0"
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10525389
• Report Number: 3004774118-2020-00211
• Device Sequence Number: 19621846
• Product Code: LXH
• UDI-Device Identifier: 10888857011076
• UDI-Public: 10888857011076
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 101-90295
• Device Lot Number: AMGA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1