MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 36CM; INTRAMEDULLARY NAIL

Catalog Number 71655136

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 06/15/2015

Event Type  Injury  

Event Description

It was reported that the surgery was extended 45 minutes to an 1 hour due to a guide rod becoming jammed in the nail.The nail was replaced.

Manufacturer Narrative

(b)(4).The associated devices were returned for evaluation.The guide rod was received separated from the nail.An attempt to insert the guide rod in the nail and subsequently remove it was conducted without issue.No further analysis was conducted.It is unclear from the available information the issue with removing the guide as reported.A review of manufacturing records did not reveal any manufacturing deviations that could have contributed to this issue.A review of complaint history revealed that we have not had any other complaints for this batch/failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: META-NAIL TIBIAL 10MM X 36CM
• 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: 4922919
• MDR Text Key: 6011157
• Report Number: 1020279-2015-00483
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061019
• 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: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71655136
• Device Lot Number: 14JM20250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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