MAUDE Adverse Event Report: INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS THREADED GUIDEWIRE K-WIRE; PIN, FIXATION, THREADED

Model Number Z16113001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/26/2021

Event Type  malfunction  

Event Description

Dr.Was sliding the screw over the guidewire and pulled out the k-wire and stated this screw place doesn't feel right.Dr.Took an x-ray and saw there was a piece of k-wire in the patient vertebrae.He determined it would cause more harm to try to remove the piece.Fda safety report id# (b)(4).

• Brand Name: THREADED GUIDEWIRE K-WIRE
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS
• MDR Report Key: 11921932
• MDR Text Key: 254076846
• Report Number: MW5101658
• Device Sequence Number: 1
• Product Code: JDW
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z16113001
• Device Lot Number: 040320
• Was Device Available for Evaluation?: Yes
• 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: 61 YR
• Patient Weight: 140