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

Catalog Number	2901-90098
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest locking screw inserter became deformed during intra-operative implant insertion.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Upon visual inspection of the device it was observed that the distal hexalobe tip of the screw inserter was deformed.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, 2 similar complaints were identified.It was observed that the instrument has been out in the field for more than 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 an everest locking screw inserter became deformed during intra-operative implant insertion.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: LOCKING SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10502589
• Report Number: 3004774118-2020-00201
• Device Sequence Number: 3593557
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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 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: 08/11/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1