MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2901-90098
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest locking screw inserter tip deformed intra-operatively.The tip would no longer fit into the interface.There were no adverse consequences to the patient.The procedure was completed successfully, without surgical delay, by using another inserter.
Additional Manufacturer Narrative
Upon visual inspection, it was observed that the distal tip of the inner shaft showed signs of fracture and damage to the male hexalobe feature.Functional analysis revealed that the tip does not fully engage the hexalobe feature of a sample everest screw.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The fracture seen on the tip is consistent with the effects of torque overloading during implant insertion.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface and reduce torque overloading.
Event or Problem Description
It was reported that an everest locking screw inserter tip deformed intra-operatively.The tip would no longer fit into the interface.There were no adverse consequences to the patient.The procedure was completed successfully, without surgical delay, by using another inserter.

• Brand Name: LOCKING SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10688284
• Report Number: 3004774118-2020-00233
• Device Sequence Number: 3933388
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: No Information
• Device Catalogue Number: 2901-90098
• Device Lot Number: KHJY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1