MAUDE Adverse Event Report: K2M, INC. SCREW BASED DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	3303-90078
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian tlif ii screw based distractor "will not easily slide" and keeps getting stuck intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Additional information: d.4.Lot # has been populated.
Event or Problem Description
It was reported that an aleutian tlif ii screw based distractor "will not easily slide" and keeps getting stuck intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that an aleutian tlif ii screw based distractor "will not easily slide" and keeps getting stuck intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: material wear was identified on the device among with discoloration around the securing screw and laser marking fading of.Functional inspection: the securing screw was loose and the distractor did not slide easily and was unstable.The device is no longer functional.Complaint history records were reviewed for this lot and no similar complaints were identified.The cause of the reported event in most likely normal wear and tear due to consistent use of the instrument throughout its lifetime.

• Brand Name: SCREW BASED DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13113896
• Report Number: 3004774118-2021-00419
• Device Sequence Number: 3693080
• Product Code: LXH
• UDI-Device Identifier: 10888857075870
• UDI-Public: 10888857075870
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2022

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: 3303-90078
• Device Lot Number: AWJM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 03/11/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/28/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown