MAUDE Adverse Event Report: K2M, INC. PROVISIONAL SPLIT DRIVER; SIZE 30; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest mi provisional split driver jammed intra-operatively.The knob of the driver would not turn and the tip would not attach to set screws.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of device history records for this lot could not be performed as a valid lot number could not be obtained.A review of complaint history records could not be performed as a valid lot code was not provided and could not be obtained.However, multiple events for jamming were identified for this catalog number, these incidents were not isolated to a specific lot number since no device was received by stryker, a conclusive cause for the failure mode could not be identified.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.H3 other text: device not returned.
Event or Problem Description
It was reported that an everest mi provisional split driver jammed intra-operatively.The knob of the driver would not turn and the tip would not attach to set screws.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.

• Brand Name: PROVISIONAL SPLIT DRIVER; SIZE 30
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10402584
• Report Number: 3004774118-2020-00181
• Device Sequence Number: 17108657
• 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): 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: 5101-90129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 08/13/2020
• 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