MAUDE Adverse Event Report: K2M, INC. NON-TAPERED DRIVER, (SHORT); SIZE 20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2112-90020
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cage was unable to be released from a capri large expandable inserter intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 20 minute surgical delay by using an alternative cage and inserter.This record captures the inserter.
Additional Manufacturer Narrative
The tip of the driver was found to be fractured off.The fracture surface is consistent with torsional overload.Complaint history records were reviewed for this lot, no similar complaints were identified.The special inserter has a size 20 hexalobe on the knob to help tighten and loosen the inner shaft.This driver was likely used in an attempt to unjam the inserter and fractured due to excessive torsional force applied.
Event or Problem Description
It was reported that a cage was unable to be released from a capri large expandable inserter intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 20 minute surgical delay by using an alternative cage and inserter.This record captures the inserter.

• Brand Name: NON-TAPERED DRIVER, (SHORT); SIZE 20
• 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: 13048128
• Report Number: 3004774118-2021-00411
• Device Sequence Number: 11159219
• Product Code: LXH
• UDI-Device Identifier: 10888857033702
• UDI-Public: 10888857033702
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/04/2022

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: 2112-90020
• Device Lot Number: MYYF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/04/2022
• 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