MAUDE Adverse Event Report: K2M, INC. MI ROD REDUCER; XT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90160
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two everest xt mi rod reducer tower tips broke off intra-operatively.The procedure was completed successfully without surgical delay.This report represents the second of the two everest xt mi rod reducer tower tips.
Event or Problem Description
It was reported that two everest xt mi rod reducer tower tips broke off intra-operatively.The procedure was completed successfully without surgical delay.This report represents the second of the two everest xt mi rod reducer tower tips.Upon investigation, the tip of the device was found to be disengaged.
Additional Manufacturer Narrative
The returned device was visually inspected.It was observed that the distal tip of the instrument had disengaged from the main body.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history records were reviewed for this lot, no similar complaints were identified.The instrument has been out in the field for more than 3 years.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue on the instrument, leading to the reported failure mode.The most likely root cause of the reported event was determined to be normal wear.

• Brand Name: MI ROD REDUCER; XT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11276375
• Report Number: 3004774118-2021-00032
• Device Sequence Number: 19708052
• Product Code: LXH
• UDI-Device Identifier: 10888857279391
• UDI-Public: 10888857279391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 5101-90160
• Device Lot Number: GGFF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1