MAUDE Adverse Event Report: K2M, INC. ANTI TORQUE ALIGNMENT TUBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 7601-90001

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2020

Event Type  malfunction  

Manufacturer Narrative

A non-conformance was initiated to investigate the root cause associated with this failure mode.The resulting investigation identified a manufacturing nonconformance specific to lot ktgg, caused by excess thread locker being applied at the distal end of this lot of instruments during manufacture.Stryker has initiated a voluntary recall on 15-oct-2020, and an urgent medical device recall letter was sent to the affected customers, notifying them of the product issue and associated risks.Device not returned.

Event Description

During device inspection, it was noted that a yukon anti-torque alignment tube was out of specification.When tested, the final tightening shaft would not properly mate with the anti-torque tube.

• Brand Name: ANTI TORQUE ALIGNMENT TUBE
• Type of Device: 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: 10832996
• MDR Text Key: 216385573
• Report Number: 3004774118-2020-00305
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10888857343948
• UDI-Public: 10888857343948
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7601-90001
• Device Lot Number: KTGG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3004774118-10/28/20-001R
• Patient Sequence Number: 1