MAUDE Adverse Event Report: K2M, INC. ADJUSTABLE INSERTER; TLIF II; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3303-90603
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an aleutian tlif adjustable inserter was jamming during intra-operative implant insertion.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully.
Additional Manufacturer Narrative
Visual inspection: it was observed that the distal threaded tip of the instrument was worn out.The instrument showed jamming issue while moving the adjustable head.Functional inspection: the instrument was functional but the adjustable head showed resistance while using the device.Complaint history records were reviewed for this lot, and no similar complaints were identified.The investigation has been performed with the information present in the investigation.It is possible that an off-axis insertion of the implant or higher forces during impaction with a mallet may lead to the observed adjustable tip jamming issue.However, a conclusive cause for the failure mode could not be determined.
Event or Problem Description
It was reported that the tip of an aleutian tlif adjustable inserter was jamming during intra-operative implant insertion.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully.

• Brand Name: ADJUSTABLE INSERTER; TLIF II
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11734583
• Report Number: 3004774118-2021-00122
• Device Sequence Number: 17198521
• Product Code: LXH
• UDI-Device Identifier: 10888857157668
• UDI-Public: 10888857157668
• 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): 08/25/2021

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 Model Number: 3303-90603
• Device Catalogue Number: 3303-90603
• Device Lot Number: MPGJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALEUTIAN TLIF II ADJUSTABLE TORQUE LIMITING SHAFT