MAUDE Adverse Event Report: K2M, INC. DRILL GUIDE, FIXED, SCREW THRU; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	201-90176
Medical Device Problem Codes	Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pyrenees fixed drill guide was not able to hold the plate.There were no adverse consequences to the patient.The procedure was completed successfully with a seven minute surgical delay.
Event or Problem Description
It was reported that a pyrenees fixed drill guide was not able to hold the plate.There were no adverse consequences to the patient.The procedure was completed successfully with a seven minute surgical delay.
Additional Manufacturer Narrative
The returned device was evaluated.No visual abnormalities were identified.Functional inspection revealed that the proximal knob and main body was loose/ not stable.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints involving this lot were identified.As the instrument has been in the field for over four years, repeated use over the lifetime of the instrument likely contributed to the observed issue.

• Brand Name: DRILL GUIDE, FIXED, SCREW THRU
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12045890
• Report Number: 3004774118-2021-00187
• Device Sequence Number: 3782252
• Product Code: LXH
• UDI-Device Identifier: 10888857030473
• UDI-Public: 10888857030473
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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 Model Number: 201-90176
• Device Catalogue Number: 201-90176
• Device Lot Number: FMHT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1