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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: one (1) device has been captured under lot kbuv.The device was received on (b)(6) 2021.Two (2) devices have been captured under lot mdpe.One device was received on (b)(6) 2021, the other on (b)(6) 2021.One (1) device has been captured under lot eaymb.The device was received on (b)(6) 2021.One (1) device has been captured under lot fgxm.The device was received on (b)(6) 2021.Five (5) of the five (5) devices have been returned for analysis.A supplemental vmsr will be submitted upon completion of the investigations.
Event or Problem Description
This report summarizes five malfunction events where an everest mi provisional split driver 'locked up' intra-operatively.Surgeries were successfully completed with another driver and no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
This report summarizes five malfunction events where an everest mi provisional split driver 'locked up' intra-operatively.Surgeries were successfully completed with another driver and no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: lot kbuv manufactured on 08/27/2019.Lot eaymb manufactured on 10/20/2016.Lot fgxm manufactured on 01/09/2017.Visual analysis of lot mdpe: in both devices, the event of jamming could not be confirmed.The knob was found to have been fractured from the handle.According to the rep, higher force was used to unthread the knob from the handle but it was wasn't successful, which led to the knob fracture.Visual analysis of lot fgxm, eaymb, kbuv: the knob was found to have been stuck with the handle internal threads.Higher force was used to unthread the knob from the handle, but it was not successful.Lot mdpe: it is possible that the devices encountered an excessive amount of reverse torque, which could have weakened the threadlocker.This can cause the handle to jam, and later fracture.The cause for the failure mode was determined to be misuse by the user, leading to fracture.Lot fgxm, eaymb, kbuv: according to the device history review, it was observed that the devices have been out in the field for more than 3 years.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue on the devices, leading to the reported failure mode.

• 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: 11746454
• Report Number: 3004774118-2021-00128
• Device Sequence Number: 3856434
• Product Code: LXH
• UDI-Device Identifier: 10888857210141
• UDI-Public: 10888857210141
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: KBUV, MDPE, EAYMB, FGXM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1