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	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2- pyrenees tapered driver tips were stripped intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.This report will capture the first of two drivers.
Event or Problem Description
It was reported that 2- pyrenees tapered driver tips were stripped intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.This report will capture the first of two drivers.
Additional Manufacturer Narrative
Visual inspection: it was observed that the hexalobe tip was deformed.The edges of the hexalobe tip were deformed in a rotational pattern and appeared dull.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Complaint history records were reviewed for this lot, five similar complaints were identified.Manufacturing records reveal that the device was about six years old at the time of event, as it was manufactured in 2015.It is likely that repeated use during the device's service life compromised the material integrity, causing tip deformation.

• 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
• MDR Report Key: 12094565
• Report Number: 3004774118-2021-00198
• Device Sequence Number: 19833610
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: DCJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1