MAUDE Adverse Event Report: K2M, INC. UNIVERSAL DRILL; SIZE Ø5.5X20 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2008-90051
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital discarded device.
Event or Problem Description
It was reported that two (2) chesapeake universal drills bent whilst preparing holes for screws intra-operatively.The surgery was completed successfully and no adverse consequences, surgical delay or medical intervention were reported.This report is for the second of the two drills.
Event or Problem Description
It was reported that two (2) chesapeake universal drills bent whilst preparing holes for screws intra-operatively.The surgery was completed successfully and no adverse consequences, surgical delay or medical intervention were reported.This report is for the second of the two drills.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.

• Brand Name: UNIVERSAL DRILL; SIZE Ø5.5X20 MM
• 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: 15147397
• Report Number: 3004774118-2022-00313
• Device Sequence Number: 17607952
• Product Code: LXH
• UDI-Device Identifier: 10888857025684
• UDI-Public: 10888857025684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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: 2008-90051
• Device Catalogue Number: 2008-90051
• Device Lot Number: MXNP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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