MAUDE Adverse Event Report: SMITH & NEPHEW, INC; PIN, FIXATION

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

K-wire broke during left hip fixation.Attending does not want to retrieve."when we were working on the left hip, 1 of the guidewires for the acutrak screws broke off within the bone.It was not prominent and therefore was left in place.".

• Type of Device: PIN, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC; 7000 w william cannon dr.; austin TX 78735
• MDR Report Key: 4840054
• MDR Text Key: 5914896
• Report Number: 4840054
• Device Sequence Number: 1
• Product Code: JDO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 05/29/2015

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: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR