MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN; SUBTROCHANTERIC DRIVER

Catalog Number 71674068

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2016

Event Type  malfunction  

Event Description

During intramedullary rodding of the left hip, and insertion of the live screw, about 10 mm of the tip of the subtrochanteric driver shaft broke while inside the screw, which was on the bone.The piece could not be retrieved.

• Brand Name: INTERTAN
• Type of Device: SUBTROCHANTERIC DRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms pkwy; cordova TN 38016
• MDR Report Key: 5658734
• MDR Text Key: 45310266
• Report Number: 5658734
• Device Sequence Number: 1
• Product Code: JDS
• 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: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 71674068
• Device Lot Number: 493644
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR