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

Catalog Number	101-90317
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when trying to final tighten a screw, the denali spinal system torque indicating wrench tip fractured intra-operatively.The procedure was completed successfully with another tool for final torquing with a 5 min surgical delay.
Event or Problem Description
It was reported that when trying to final tighten a screw, the denali spinal system torque indicating wrench tip fractured intra-operatively.The procedure was completed successfully with another tool for final torqueing with a 5 min surgical delay.
Additional Manufacturer Narrative
Upon visual inspection, it was observed that the tip of the device had fractured.Heavy wear of its laser markings and main body discoloration were observed as well.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was determined that over torqueing created excessive force at the distal tip, compromising the material integrity and ultimately resulting in the observed fracture.

• Brand Name: TORQUE INDICATING WRENCH; SIZE 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10995584
• Report Number: 3004774118-2020-00345
• Device Sequence Number: 728074
• Product Code: LXH
• UDI-Device Identifier: 10888857011267
• UDI-Public: 10888857011267
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/26/2021

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: 101-90317
• Device Lot Number: HHNN005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1