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

Catalog Number	2901-90098
Medical Device Problem Codes	Material Twisted/Bent (2981); No Apparent Adverse Event (3189)
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 second of the two inserters.
Additional Manufacturer Narrative
Visual and functional inspection were performed.It was observed that the distal hexalobe tip of the screw inserter showed signs of wear.The screw inserter was able to engage with the screw as intended.No signs of tip disengagement was observed.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Since the reported issue was not confirmed, and the instrument functioned as intended, no root cause for the reported event could be determined.
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 second of the two inserters.
Additional Manufacturer Narrative
D.4 and d.9 were updated to reflect product return information.
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 second 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: 10336023
• Report Number: 3004774118-2020-00153
• Device Sequence Number: 13721605
• 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): 10/12/2020

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: HFJF
• 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; 09/27/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/11/2020; 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1