MAUDE Adverse Event Report: REQUESTED BUT NOT RECEIVED; K-WIRE

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2016

Event Type  malfunction  

Event Description

Surgery to remove right tha, i+d right hip and thigh and placement of abx cement spacer for septic hip.Two to three mm tip of k-wire missing, confirmed on x-ray.Surgeon stated he will remove it when pt returns in 8 weeks for planned hip surgery.Surgeon dictated that he did not wish to remove the abx cement spacer to get to the fragment and that the fragment is within in the bone and in no danger of causing any injury.

• Type of Device: K-WIRE
• Manufacturer (Section D): REQUESTED BUT NOT RECEIVED
• MDR Report Key: 5705832
• MDR Text Key: 46821723
• Report Number: 5705832
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016,04/26/2016

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?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1