MAUDE Adverse Event Report: AESCULAP AG MIOS REAMER SHANK ZIMMER; HIP ENDOPROSTHETICS

Model Number NF935R

Device Problem Material Fragmentation (1261)

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

Event Date 12/14/2023

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 the product nf935r - mios reamer shank zimmer.According to the complaint description, the handle was rotating but the tip of the reamer did not rotate.The handle has to be switched to a straight one for reaming.After the surgery, damage of the connection part was confirmed.A metal fragment was detected inside the shaft.As usual practice, a x-ray was taken direct post-operative.There was no foreign object detected on the image.There was no described 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

Additional information: d9 - product returned.H3 - yes, evaluation.H6 - codes updated.Investigation results: visual inspection: aesculap ag carried out a visual and microscopic inspection.The inspection revealed that the proximal and distal joints of the cardan shaft are extremely worn due to overload - the proximal joint is so badly worn that the forks have worn through to the pin holes and the joint has torn apart.The z-tubes show severe scratches on the inside where the broken joint is located.The device was also returned mixed, which means that all components have different compatibility numbers.The friction between the joints also generated a lot of heat, as shown by the tempering colors on the joint parts.The pins used to connect the joint are missing.Further observations: - signs of wear were also noted on the two connections.- some scratches and nicks were found on the indexing handle and the housing 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.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - malfunction (not later than 30 days).The assessment for the reportability of this malfunction was based on applicable product risk analysis review.Conclusion/preventive measures: the device was used in mixed condition.According to electronic instructions for use (eifu), the components of one reamer handle must never be mixed with components of another reamer handle as components are compatible with each other.These components have been in use for many years: cardan shaft year of manufacture 2006, z-tube year of manufacture 2007, handle 2008.It is not known how many surgical procedures (cycles) these devices have undergone in the course of their service life.The problem for this device is attributed to heavy wear due to the use of components with different compatibility numbers and the service life resulting from the age of the components.There is no indication fo a material-, manufacturing- or design- related failure.Based upon the investigation results, a capa is not necessary.

• Brand Name: MIOS REAMER SHANK ZIMMER
• 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: 18464114
• MDR Text Key: 332986130
• Report Number: 9610612-2023-00288
• Device Sequence Number: 1
• Product Code: HTO
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NF935R
• Device Catalogue Number: NF935R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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