MAUDE Adverse Event Report: SYNTHES SYNTHES; 1.1MM GUIDEWIRE

Model Number 900.625

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

K wire tip broke off and embedded in patient's left patella during procedure.Original attempt by surgeon to remove unsuccessful.Decision by physician to attempt no further removal due to risk outweighing benefit of removal.Tip retained without any complications.

• Brand Name: SYNTHES
• Type of Device: 1.1MM GUIDEWIRE
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 7402252
• MDR Text Key: 104689911
• Report Number: MW5076352
• Device Sequence Number: 1
• Product Code: LRN
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900.625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 77