MAUDE Adverse Event Report: K2M, INC. TORQUE INDICATING WRENCH; SIZE 25, MI; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	1001-90133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled revision, the tip of a denali mi torque indicating wrench fractured while attempting to remove a set screw intra-operatively.The procedure was completed successfully with a screw removal tool, and no surgical delay.No adverse consequences, or medical intervention were reported.
Event or Problem Description
It was reported that during a scheduled revision, the tip of a denali mi torque indicating wrench fractured while attempting to remove a set screw intra-operatively.The procedure was completed successfully with a screw removal tool and no surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual analysis: it was observed that the male hexalobe feature at the distal tip was fractured.Functional inspection: the torque wrench was tested for calibration and all measurements were within specification.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, and 11 similar complaints were identified.As the instrument was manufactured in 2011, repeated use over the lifetime of the instrument likely contributed to the failure.

• Brand Name: TORQUE INDICATING WRENCH; SIZE 25, MI
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11008385
• Report Number: 3004774118-2020-00348
• Device Sequence Number: 4496303
• Product Code: LXH
• UDI-Device Identifier: 10888857001121
• UDI-Public: 10888857001121
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/27/2021

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: 1001-90133
• Device Lot Number: AKKH014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1