MAUDE Adverse Event Report: AESCULAP AG INSERTION INSTR.W/BALL-SHAPED TRIGON STR; HIP ENDOPROSTHETICS

Model Number ND844R

Device Problem Difficult to Insert (1316)

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

Event Date 05/10/2023

Event Type  Injury  

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 nd844r - insertion instr.W/ball-shaped trigon str.According to the complaint description, the product could not be removed after inserting the stem.Using pliers and a hammer the product could be removed but the stem was also removed.After removing, the customer used a product with a pencil-type tip instead.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components nj614t - bicontact e plasmapore-¿cap 8/10 size 14 - lot 52621310.

Event Description

Involved components: nj614t - bicontact e plasmapore-cap 8/10 size 14 - lot 52621310.

Manufacturer Narrative

Investigation: the working end of the instrument is damaged / deformed.Hardness target: 420+110 hv5, hardness actual: 495 hv5.Device history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.There are no further similar complaints within this batch.The current failure rate is within the risk analysis and therefore acceptable according to din en iso 14971; severity was 2(5) and probability 3(5).Conclusion and root cause: the deformation of the working end is the reason for the jamming with the hip stem.The hardness of the product meets the specifications.A final root cause for the failure cannot be determined.No hints for a manufacturing related error could be ascertained.Preventive measures: based upon the investigation results, a capa is not necessary.

• Brand Name: INSERTION INSTR.W/BALL-SHAPED TRIGON STR
• 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: 17015435
• MDR Text Key: 316196044
• Report Number: 9610612-2023-00129
• Device Sequence Number: 1
• Product Code: LXH
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ND844R
• Device Catalogue Number: ND844R
• Device Lot Number: 52500006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• 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
• Treatment: NJ614T - LOT 52621310.; NJ614T - LOT 52621310.
• Patient Outcome(s): Required Intervention