MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN INSTRUMENTS; HONEYCOMB

Catalog Number 71674075

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that the honeycomb guide was not intact on the back field after having been used.Extensive further investigation using radiology revealed the presence of the missing portion of the honeycomb in the patients femoral canal.Multiple attempts at removal/retrieval of the honeycomb piece utilizing a myriad of instruments all failed.Due to the location of the broken piece in the femur, the procedure was changed to a dynamic hip screw (dhs) by the surgeon.Appropriate instruments were obtained and the procedure was completed without further inc.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The associated complaint device was not returned.Without the actual product involved, our investigation cannot proceed.Dhr unable to be performed due to the lot number being so old and paperwork unavailable.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: INTERTAN INSTRUMENTS
• Type of Device: HONEYCOMB
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4522346
• MDR Text Key: 5360986
• Report Number: 1020279-2015-00079
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,health professional,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71674075
• Device Lot Number: 489288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention