MAUDE Adverse Event Report: STRYKER K-WIRE; PIN, FIXATION, SMOOTH

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported during an open reduction internal fixation (orif} of an acetabular fracture on (b)(6) 2016, the surgeon was attempting to pass a 3mm guide wire through the sliding mechanism and the guide wire got stuck.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: K-WIRE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17526055
• MDR Text Key: 321416877
• Report Number: MW5132995
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2016

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1