MAUDE Adverse Event Report: AESCULAP AG BIPOLAR CUP HANDLE F/TRIAL HEADS CVD; HIP ENDOPROSTHETICS

Model Number NF771R

Device Problem Material Fragmentation (1261)

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

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the device was not available for investigation but the issue was discussed with an expert of r&d.A picture was provided by the customer.The traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer.This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.A root cause and a clear conclusion can not be determined due to the lack of information and components.It is possible that a usage related failure led to the described issue.If the instrument is connected to the trial implant in a proper way such a abrasion should not occur.Correct connection should avoid and prevent abrasion.A capa is not necessary.

Event Description

It was reported that there was an issue with a bipolar cup handle f/trial heads cvd.According to the complaint description plastic abrasion when connecting the insertion instrument to the trial implant.There was no patient harm.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: (updated) pictures of the device were provided by customer.The device was not available for investigation.According to the market feedback and market surveillance, statistical analysis, this is no systematic failure.Based on the current information and without a product for investigation, a root cause can not be determined.If the instrument is connected to the trial implant in a proper way (thread correctly locked to counterpart), such an abrasion should not occur.Therefore, a correct connection is important to prevent an abrasion.Furthermore, it is possible that a slightly damaged thread on the instrument led to the failure pattern.Based on the information available as well as the result of the investigation, we exclude an error caused by manufacturing or caused by material.

• Brand Name: BIPOLAR CUP HANDLE F/TRIAL HEADS CVD
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10413990
• MDR Text Key: 204727516
• Report Number: 9610612-2020-00367
• Device Sequence Number: 1
• Product Code: HWT
• 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
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NF771R
• Device Catalogue Number: NF771R
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1