MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN 44 +0 HEAD TRIAL; PROSTHSIS,HIP, HMI-,TRUNNIONBARING,FEMORAL, METAL/POLYACETAL

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, the head trial broke while being used inside of the patient.Trialing was completed with the faulty device.Surgery was not delayed.The patient did not experience any other complication.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.As device information was not made available, device history record , risk management review and complaint history review cannot be completed.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: UNKNOWN 44 +0 HEAD TRIAL
• Type of Device: PROSTHSIS,HIP, HMI-,TRUNNIONBARING,FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10471689
• MDR Text Key: 204930787
• Report Number: 1020279-2020-04296
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention