MAUDE Adverse Event Report: EXACTECH, INC. ERGO; 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 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): cannulated reamers, 315-52-63, modular cannulated center peg drill.

Event Description

As reported, the cannulated reamers and center drill gets stuck on the kwire.Threaded k-wire for new ergo instruments broke at the end of the threaded part.Piece broke off in the glenoid when removing the pin.Part of the threaded piece was removed and part of it was left in patient.Patient was discharged home without complications.

Manufacturer Narrative

Section h10: (h3) per capa2019-52, the fractured k-wire reported in case (b)(4) was likely the result of unique misuse conditions, resulting in excessive bending force application to the k-wire, that were not identified during validation and verification activities.These may be surgeon-specific and could not be replicated with subsequent simulated use testing.A recall was initiated for the 3.2mm threaded k-wire (321-52-06).(h7) recall.(h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z-0168-2020.

• 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: 9621803
• MDR Text Key: 189079365
• Report Number: 1038671-2020-00013
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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
• Date Manufacturer Received: 01/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0168-2020
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention