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

Model Number	5101-90129
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot nhfh (1): device returned 16 june 2022.Lot kjdy (1): device returned 05 july 2022.Lot nhfh (1): device not yet returned.Lot kupb (1): device not yet returned.Lot kjdy (2): devices not yet returned lot ewgga (1): device returned 24 june 2022.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures seven instances of intraoperative everest provisional split driver jamming.In one (of seven) instances, the reported event was noted during sterilization; there was no procedure associated with the event and no patient involvement.In four (of seven) instances, the associated procedure was completed successfully with a ten-minute surgical delay and no adverse consequence to a patient or user.In two (of seven) instances, the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot kjdy (2): manufacture date 23 december 2019.Device not returned.Lot nhfh (1): manufacture date 28 january 2021.Device not returned.Lot kupb (1): device not returned.Lot nhfh (1): manufacture date 28 january 2021.Device returned 16 june 2022.Lot kjdy (1): manufacture date 23 december 2019.Device returned 05 july 2022.Lot ewgga (1): manufacture date 29 september 2016.Device returned 24 june 2022.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures (b)(4) instances of intraoperative everest provisional split driver jamming.In (b)(4) instances, the reported event was noted during sterilization; there was no procedure associated with the event and no patient involvement.In (b)(4) instances, the associated procedure was completed successfully with a ten-minute surgical delay and no adverse consequence to a patient or user.In (b)(4) instances, the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• 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
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15138157
• Report Number: 3004774118-2022-00310
• Device Sequence Number: 5614627
• 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: 7
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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 Model Number: 5101-90129
• Device Catalogue Number: 5101-90129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 10/01/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown