MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MOD CANNULATED PEG DRILL

Catalog Number 315-52-63

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

While drilling for the center hole that will accommodate the cage of the implant.As the surgeon began to drill into the bone in the usual fashion, the 3.2mm cannulated drill shattered in the patient¿s glenoid.Once the remaining part of the drill was removed from the k-wire, the surgeon realized the k-wire also broke/snapped in the patient¿s glenoid.The k-wire appeared to have broken at the last thread before the smooth part of the k-wire.The surgeon spent an extra 5-10 minutes trying to remove a piece of the shattered drill and was able to remove one piece of three from the glenoid.The other two pieces of the 3.2 cannulated drill and the threaded tip of the broken 3.2 k-wire pushed through the patient¿s glenoid and was retained in the patient.The surgeon then implanted the baseplate and drilled for screws as normal.The rest of the case went as planned.Post-op x-rays were taken following surgery and confirmed that two pieces of the drill and the one piece of the k-wire is retained in the glenoid bone and does not appear to be floating, it is in the bone.The patient was under anesthesia for extra time due to this event.The patient left the or in stable condition.The broken drill and k-wire will be returned to the manufacturer.

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.(h6) evaluation codes: 3165, 1069.Section h11: the following sections have corrected information: (section f) please disregard f6 and f8.These were entered in error.(h1) type of reportable event: malfunction.No information provided in the following section(s): a3, a4, a5, b6, b7, d6, d7, d11, g5, g8, h4.

• Brand Name: EQUINOXE
• Type of Device: MOD CANNULATED PEG DRILL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8666490
• MDR Text Key: 146919876
• Report Number: 1038671-2019-00323
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862558176
• UDI-Public: 10885862558176
• 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

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 315-52-63
• Device Lot Number: 144604022
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/28/2019
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0168-2020
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR