MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 38CM 125D LT; INTRAMEDULLARY NAIL

Catalog Number 71675247

Device Problems Migration or Expulsion of Device (1395); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 05/24/2015

Event Type  Injury  

Event Description

It was reported that the surgery was delayed for more than an hour due to drill becoming jammed in the nail and the set screw migrating into the lag screw hole of the nail.

Manufacturer Narrative

(b)(4).The associated device was returned and evaluated.Visual inspection confirms that the set screw is not positioned correctly.Our investigation could not determine a specific cause of this incorrect positioning.Part is 3 years old and exhibits signs of normal wear/usage.Per visual inspection, set screw was in too far.An attempt was made to drill out the set screw and damaged the part.The information available as a result of this investigation indicates that corrective/ preventive action is warranted.This issue has been submitted to our capa process in accordance with applicable internal capa procedures.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigation further as necessary.

• Brand Name: INTERTAN 11.5MM X 38CM 125D LT
• Type of Device: INTRAMEDULLARY NAIL
• 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: 4839029
• MDR Text Key: 5913987
• Report Number: 1020279-2015-00374
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Catalogue Number: 71675247
• Device Lot Number: 11KM15671A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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