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

Model Number 5101-90129

Device Problem Failure to Eject (4010)

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

Event Date 07/01/2022

Event Type  malfunction  

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 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.

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 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
• 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: 15138157
• MDR Text Key: 302691559
• Report Number: 3004774118-2022-00310
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10888857210141
• UDI-Public: 10888857210141
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 10/01/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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