MAUDE Adverse Event Report: K2M, INC. TAPERED DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	201-90118
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of two pyrenees tapered drivers showed signs of wear and tear outside the operating room.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of two screwdrivers.
Event or Problem Description
It was reported that the tips of two pyrenees tapered drivers showed signs of wear and tear outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of two pyrenees screwdrivers.
Additional Manufacturer Narrative
The instrument was returned, visually and microscopically inspected.Upon review of the part, it was observed that the male hexalobe feature at the distal tip was slightly deformed.Complaint history was reviewed for the corresponding lot number, and one similar complaint was identified.The most likely cause of the reported event was determined to be excessive torsional load or heavy use of the instrument, as communicated by the field representative.

• Brand Name: TAPERED DRIVER; SIZE 10
• 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: 12304756
• Report Number: 3004774118-2021-00246
• Device Sequence Number: 14335822
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 201-90118
• Device Lot Number: NBMW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/22/2021
• 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