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

Model Number 7601-90003

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 307119607
• Report Number: 3004774118-2022-00365
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 01/01/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1