MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; HIP SYSTEM INSTRUMENTATION

Catalog Number 71364006

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the instrument broke during surgery and fragments fell into surgical site.The surgeon carried out debridement to find fragments.It is possible there are unretrieved device fragments.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned device revealed the jaws of the t handle have fractured off.The fractured pieces were not returned.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The device is worn and show significant signs of use.The device was manufactured in 2011.The t-handle fractured in the jaws of the handle, potentially from static bending or torsional overload.An overload fracture can occur if the mechanical loads applied to the device exceed the strength of the material.Our investigation did not determine a specific cause of the stated failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: T-HANDLE
• Type of Device: HIP SYSTEM INSTRUMENTATION
• 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: 5533018
• MDR Text Key: 41406465
• Report Number: 1020279-2016-00270
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71364006
• Device Lot Number: 11FM15759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2011
• 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