MAUDE Adverse Event Report: K2M, INC. PROVISIONAL SPLIT DRIVER; SIZE 30; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	5101-90129
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three everest mi provisional split drivers jammed intra-operatively.The drivers were not able to attach to the set screw and the knobs would not turn.There were no adverse consequences to the patient.The procedure was completed successfully, without surgical delay, by using an alternate instrument.This report represents the first of the three drivers.
Event or Problem Description
It was reported that three everest mi provisional split drivers jammed intra-operatively.The drivers were not able to attach to the set screw and the knobs would not turn.There were no adverse consequences to the patient.The procedure was completed successfully, without surgical delay, by using an alternate instrument.This report represents the first of the three drivers.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.As the device was not available for inspection, the reported failure mode could not be confirmed, and a root cause could not be established.

• Brand Name: PROVISIONAL SPLIT DRIVER; SIZE 30
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10335657
• Report Number: 3004774118-2020-00151
• Device Sequence Number: 19101002
• Product Code: LXH
• UDI-Device Identifier: 10888857210141
• UDI-Public: 10888857210141
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 10/22/2020

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: 5101-90129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1