MAUDE Adverse Event Report: AESCULAP AG TRIAL INSERT G 36MM POST.WALL; HIP ENDOPROSTHETICS

Model Number NT613

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with nt613 - trial insert g 36mm post.Wall.According to the complaint description, the surgeon was unable to fix the trial insert in the acetabular cup despite several attempts.The surgeon then attempted the implant 36mm pw insert.The insert fit in the acetabulum successfully.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation results: visual investigation: we made a visual and microscopical inspection of the product.The complained device shows visible traces of use.Furthermore the trail insert was forwarded to the responsible manufacturing department for further investigation.The device shows signs of use.The described error description was checked wthe the following products.The following products were used for this purpose: nk669k 52797287; nv052t 52788983.Result: the function was given with the cup, the ball head and in combination.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: a clear conclusion regarding the root cause for the mentioned failure cannot be determined.The provided device shows no hints regarding a manufacturing or material related error.During the functional test carried out by the responsible manufacturing department, the mentioned failure could not be rectified.Based on the signs of use, it can be assumed that the product has been used several times probably successful, otherwise the product would have been discarded/sorted out long ago.It could be possible that the user inserted the device the wrong way.But this is only speculative.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably usage-related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results, a capa is not necessary.

• Brand Name: TRIAL INSERT G 36MM POST.WALL
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15699189
• MDR Text Key: 302696253
• Report Number: 9610612-2022-00326
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT613
• Device Catalogue Number: NT613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention