MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 3.2MM THREADED K-WIRE STERILE

Catalog Number 321-52-06

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that during a shoulder procedure, a kwire was used during drilling.Upon removing the drill off the kwire, it was noted that the k-wire had snapped where the threads of the tip meet the solid part of the wire and the threaded tip of the kwire was retained in the patient.The patient left the or stable.Post op x-rays were obtained confirming the threaded tip is in the glenoid bone.No other information is available at this time.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(e3) occupation: physician.(h3) per capa2019-52, the fractured k-wire and cannulated drill bit reported was likely the result of insufficient validation and verification requirements.Additionally, the operative technique was not adequate to instruct the users to avoid applying a bending moment during use of the k-wire.A recall was initiated for the 3.2mm threaded k-wire (321-52-06).Additionally, the design of the 3.2mm k-wire and the cannulated drill bit are being updated, the risk management plan is being updated to include new wire related risks, and the ergo operative technique is being updated to instruct users to avoid off-axis use of the instruments.

• Brand Name: EQUINOXE
• Type of Device: 3.2MM THREADED K-WIRE STERILE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8864434
• MDR Text Key: 189070999
• Report Number: 1038671-2019-00394
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-52-06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0168-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 108