MAUDE Adverse Event Report: K2M, INC. MI ROD INSERTER, BEARING DRIVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90159
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest xt mi rod inserter, bearing drive was not functioning as intended intra-operatively during implant insertion.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the device appeared intact upon receipt.No deformities or abnormalities were observed.Functional inspection: the proximal knob was able to rotate; however, the pin that secures the rod at the distal tip would not engage.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.The most likely cause of the reported event was determined to be user error.Overturning the proximal knob in a clockwise or counter-clockwise manner can damage internal components, preventing the distal pin from engaging a rod.
Event or Problem Description
It was reported that an everest xt mi rod inserter, bearing drive was not functioning as intended intra-operatively during implant insertion.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: MI ROD INSERTER, BEARING DRIVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10341714
• Report Number: 3004774118-2020-00157
• Device Sequence Number: 3749124
• Product Code: LXH
• UDI-Device Identifier: 10888857279407
• UDI-Public: 10888857279407
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 09/25/2020

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: 5101-90159
• Device Lot Number: HBUK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1