MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	2901-90098
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two everest locking screw inserter tips were damaged intra-operatively.The instruments repeatedly became unlocked and loosened during insertion.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the first of the two inserters.
Event or Problem Description
It was reported that two everest locking screw inserter tips were damaged intra-operatively.The instruments repeatedly became unlocked and loosened during insertion.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the first of the two inserters.
Additional Manufacturer Narrative
D.4 and d.9 were updated to reflect product return information.
Additional Manufacturer Narrative
Visual inspection: the device was inspected.It was observed that the distal hexalobe tip of the screw inserter was deformed.Device and complaint history records were reviewed and no relevant manufacturing issues were identified; however, 2 similar complaints were identified.The deformation seen on the tip is consistent with the effects of torque overloading during implant insertion.It was observed that the instrument has been out in the field for about 4 years.Factors such as consistent use of the instrument may cause fatigue, leading to instrument failure as reported.The root cause for this event is determined to be normal wear.
Event or Problem Description
It was reported that two everest locking screw inserter tips were damaged intra-operatively.The instruments repeatedly became unlocked and loosened during insertion.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the first of the two inserters.

• Brand Name: LOCKING SCREW INSERTER
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10335927
• Report Number: 3004774118-2020-00152
• Device Sequence Number: 1073780
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/13/2020

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: 2901-90098
• Device Lot Number: FDRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 09/15/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/11/2020; 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1