MAUDE Adverse Event Report: LDR MÉDICAL MULTIFONCTION HANDLE; T-HANDLE

Model Number N/A

Device Problems Mechanical Problem (1384); Failure to Disconnect (2541); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

No information enough about the event which occured.Additional information were requested.Possible serious injury.Device not received yet.

Event Description

Event was reported as an issue with "t-handle." according to the reporter, the t-handle would not release the driver; it took 20 minutes to get the driver out.Several attempts were made to have more information.Product seems to be send back to the manufacturer but not received yet.

Manufacturer Narrative

No information enough about the event which occured.Attempts have been made and no further information has been provided.Device not received yet.

Event Description

Event involves an unknown product, torque handle.According to the reporter, the t-handle would not release the driver, it took 20 minutes to get the driver out.Attempts have been made and no further information has been provided.According to reporter, product will be send back to the manufacturer but not received yet.

Manufacturer Narrative

No information enough about the event which occured.Attempts have been made and no further information has been provided.No event date provided.Description was completed regarding the potential device to attribute an appropriate code.Device product code cannot be determined as the identity of the device is unknown.Possible serious injury.

Event Description

Event involves an unknown product.T-handle would correspond to a instrument handle that can be assemble to different mating instruments.It enables to use the mating instrument.

Event Description

Event involves an unknown product.T-handle would correspond to a instrument handle that can be assemble to different mating instruments.It enables to use the mating instrument.

Manufacturer Narrative

After several attempts to obtain information, it was not possible to get the reference and lot number of the product.It was not possible to perform the review of the device history records.No additional information was received, follow-up medwatch was submitted to send the result of the investigation & the root cause in order to close the complaint.Based on the review of the case and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.Requests for additional information and product return did not receive a response.It could not even be possible to make hypothesis about the root cause of the event.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: unknown.

• Brand Name: MULTIFONCTION HANDLE
• Type of Device: T-HANDLE
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7003488
• MDR Text Key: 92898682
• Report Number: 3004788213-2017-00178
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2018

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 Model Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 10/13/2017; 10/13/2017
• Supplement Dates FDA Received: 11/17/2017; 11/22/2017; 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1