MAUDE Adverse Event Report: BRASSLER K-WIRE

Model Number K-WIRE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

During an orif of a proximal middle finger, a k-wire broke in a sub-cortical position during placement in the proximal phalanx.The k-wire was not able to be retrieved without an open incision and significant destruction of the bone, it was left in place.

• Brand Name: K-WIRE
• Type of Device: WIRE
• Manufacturer (Section D): BRASSLER
• MDR Report Key: 5440598
• MDR Text Key: 38420356
• Report Number: MW5060201
• Device Sequence Number: 1
• Product Code: LRN
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K-WIRE
• Device Catalogue Number: KM172-24-355
• Device Lot Number: NK3EC
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 41