MAUDE Adverse Event Report: DEPUY SYNTHES SYNTHES (KIRSCHNER) K-WIRE; PIN, FIXATION, SMOOTH

Catalog Number 292.12

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

Pt underwent orif right trimalleolar ankle fracture.During the procedure, there was visualization under fluoroscopy whereby the tip of the k-wire was seen between the medial malleolus screw.It was confirmed to be in the bone.The decision was made to leave the k-wire tip in due to removal would have been more harmful.

• Brand Name: SYNTHES (KIRSCHNER) K-WIRE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): DEPUY SYNTHES; west chester PA
• MDR Report Key: 7805617
• MDR Text Key: 118092929
• Report Number: MW5079302
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 66