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

Model Number	7601-90003
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot ghec (1): manufacture date 02 february 2018, device returned 25 july 2022.Lot pfvt (1): manufacture date 10 august 2021, device returned 20 july 2022.Lot nvnm (1): device returned 20 july 2022.Lot hvwe (1): manufacture date 01 february 2019, device returned 20 july 2022.Lot jjan (1): manufacture date 23 july 2019, device returned 20 july 2022.Lot pfvt (1): manufacture date 10 august 2021, device returned 25 july 2022.Lot nvnk (2): device returned 16 september 2022.Lot mfev (2): device returned 27 october 2022.Lot teen (2): device returned 06 october 2022.
Event or Problem Description
This record is a consolidation of (b)(4) records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures twelve instance of intraoperative yukon screw inserter coupling issues (jamming).The associated procedures were completed successfully with no surgical delay and no adverse consequence to a patient.
Additional Manufacturer Narrative
Lot ghec (1): manufacture date 02 february 2018.Device returned 25 july 2022.Lot pfvt (1): manufacture date 10 august 2021.Device returned 20 july 2022.Lot nvnm (1): device returned 20 july 2022.Lot hvwe (1): manufacture date 01 february 2019.Device returned 20 july 2022.Lot jjan (1): manufacture date 23 july 2019.Device returned 20 july 2022.Lot pfvt (1): manufacture date 10 august 2021.Device returned 25 july 2022.Lot nvnk (2): manufacture date 07 april 2021.Device returned 16 september 2022.Lot mfev (2): manufacture date 18 january 2021.Device returned 27 october 2022.Lot teen (2): manufacture date 31 march 2022.Device returned 06 october 2022.
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures twelve instance of intraoperative yukon screw inserter coupling issues (jamming).The associated procedures were completed successfully with no surgical delay and no adverse consequence to a patient.

• Brand Name: SCREW INSERTER
• 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: 15694628
• Report Number: 3004774118-2022-00365
• Device Sequence Number: 20651042
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 12
• 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): 01/19/2023

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: 7601-90003
• Device Catalogue Number: 7601-90003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2022
• Supplement Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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