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

Catalog Number 321-52-06

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

Surgeon was drilling the center hole when it broke off in the glenoid.The threaded tip of the ergo kwire broke off the wire into the glenoid.Tip is still in patient.

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: ERGO
• Type of Device: 3.2MM THREADED K-WIRE STERILE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8910280
• MDR Text Key: 154890062
• Report Number: 1038671-2019-00411
• 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

• Date FDA Received: 08/20/2019
• 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
• Distributor Facility Aware Date: 08/08/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention