MAUDE Adverse Event Report: K2M, INC. DUAL ACTION ROD REDUCER; DRAGONFLY; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	801-90038
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: the device was inspected and found to have a deformed distal tip.One of the four clamping jaws was bent outward which is consistent with the reported event details.It was also found that the primary swiveling component of the gold lever was galling.Signs of wear could be seen around the component.Functional inspection: the device was tested by depressing both of the levers and checking for issues.A considerable amount of resistance could be felt while depressing the gold lever which indicates that galling has occurred.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Since the instrument was manufactured over 5.5 years ago (and was over three (3) years old at the time of failure), the issue can most likely be attributed to routine wear/tear and cleaning/reprocessing of the device.Routine wear/tear and cleaning/reprocessing of the device appears to have worn out the original lubrication which led to galling and eventual device failure.When the instrument was locked intraoperatively, the swiveling component was most likely frozen due to the combination of insufficient lubrication, progressive galling, and high locking force.As a result, the failure mode was confirmed and the most likely root cause for the issue was determined to have been normal wear/tear and cleaning/reprocessing of the device.
Event or Problem Description
It was reported that a mesa dual action rod reducer dragonfly tip became deformed and was not able to be removed after intra-operative locking.The surgeon removed a portion of the patient's bone surrounding the instrument in an attempt to remove it.The surgeon was finally able to remove the instrument with a mallet and the procedure was completed successfully with a 10-20 minute surgical delay.
Event or Problem Description
It was reported that a mesa dual action rod reducer dragonfly tip became deformed and was not able to be removed after intra-operative locking.The surgeon removed a portion of the patient's bone surrounding the instrument in an attempt to remove it.The surgeon was finally able to remove the instrument with a mallet and the procedure was completed successfully with a 10-20 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and found to have a deformed distal tip.One (1) of the four (4) clamping jaws was bent outward which is consistent with the reported event details.It was also found that the primary swiveling component of the gold lever was galling.Signs of wear could be seen around the component.Functional inspection: the device was tested by depressing both of the levers and checking for issues.A considerable amount of resistance could be felt while depressing the gold lever which indicates that galling has occurred.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Since the instrument was manufactured over 5.5 years ago, and was over three (3) years old at the time of failure, the issue can most likely be attributed to routine wear/tear and cleaning/reprocessing of the device.Routine wear/tear and cleaning/reprocessing of the device appears to have worn out the original lubrication which led to galling and eventual device failure.When the instrument was locked intraoperatively, the swiveling component was most likely frozen due to the combination of insufficient lubrication, progressive galling, and high locking force.As a result, the failure mode was confirmed and the most likely root cause for the issue was determined to have been normal wear/tear and cleaning/reprocessing of the device.

• Brand Name: DUAL ACTION ROD REDUCER; DRAGONFLY
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10280019
• Report Number: 3004774118-2020-00145
• Device Sequence Number: 16752332
• Product Code: LXH
• UDI-Device Identifier: 10888857143098
• UDI-Public: 10888857143098
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• 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): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 801-90038
• Device Lot Number: AMWW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other