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

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported a revision surgery was performed to remove implant hardware.During removal, hardware broke thus making it not possible to remove as desired.Hardware component left in patient.

Manufacturer Narrative

Additional information: the associated complaint device was not returned for evaluation.This case reported the head of the compression screw broke off during the hardware removal attempt of intertan nail.Reportedly, the surgeon planned to remove the intertan nail prior to a below knee amputation, however, ¿the compression screw broke about one inch from screw head; thus not making it possible to remove the implant as desired¿.The single photo of the radiologic image shows lack of compression screw head in the intertan nail.It is unclear if the device was partially or completely removed.There was no delay in surgery or patient harm reported due to the event.Although requested, there is no additional supporting clinical documentation provided and the products have not been returned for analysis.Therefore it is not possible to perform a thorough clinical assessment.No product information was provided (part number or batch number).Without the actual product involved, our investigation cannot proceed.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.

• Type of Device: TRIGEN INTERTAN
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5513725
• MDR Text Key: 40773049
• Report Number: 1020279-2016-00245
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention