MAUDE Adverse Event Report: AESCULAP AG HANDLE THA F/LATERAL APPROACH OFFSET LT.; HIP ENDOPROSTHETICS

Model Number NT004R

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with handle, instrument.The handle was difficult to lock and it was attempted several times.With the profiler handle being unlocked, staff was able to hold the profiler while grasping the knob by hand and pulled it out with pliers.After that, the implant was successfully inserted and the surgery was completed successfully.The surgical delay due to this handle malfunction was about 10 minutes.Additional information was not provided nor available was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Event Description

Additional case with the cc notification (b)(4) was created: see below.Associated medwatch report: these case (b)(4) is related to (b)(4).9610612-2020-00223 (nt004r 51719248).9610612-2020-00307 (nt004r 51939080).

Manufacturer Narrative

See b5.

Manufacturer Narrative

Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: HANDLE THA F/LATERAL APPROACH OFFSET LT.
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10178847
• MDR Text Key: 195946445
• Report Number: 9610612-2020-00223
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT004R
• Device Catalogue Number: NT004R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1