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

Model Number NF936R

Device Problem Mechanical Jam (2983)

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

Event Date 04/25/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with the product nf936r - mios reamer shank harris according to the complaint description, the instrument cannot be assembled.The teflon sleeve on the inside has expanded.As a result, it is no longer possible to insert the inner tube into the outer sleeve without force.A replacement instrument was not available.The surgery could still be completed with competitor products.Additional medical intervention was necessary.This event prolonged the surgery for 20 minutes.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference 100033001 (400599675).

Manufacturer Narrative

Investigation results: visual investigation: during the examination it could be confirmed that the device is difficult to assemble.The offset reamer handle does not assemble/ disassemble as intended due to oversized teflon bearings.In order for the product to be assemble/ disassemble more force is required than the intended one.In 2021, a material change was made on the basis of continuous product maintenance.This made the affected product less susceptible to the failure mode described.The affected product was manufactured prior to the material change.He reporting decision is based upon the review of the applicable risk analysis.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to manufacturer specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against this batch number.The review of the risk analysis after investigation revealed that the applicable failure mode is rated with a severity of 3 out of 5 which means significant harming for the patient e.G.Moderate injury, repairable injury or a disability that requires additional medical intervention, allergic reaction, severe pain.Based upon risk management review, we conclude that there has been no change in the benefit/risk assessment of these products and the prevalence and seriousness of already known risks did not increase.Acceptable probability of occurrence: < 500 ppm actual failure occurrence: 59 ppm the review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: a capa was completed on february 18th to address this issue.It was determined that the root cause was related to the cleaning and sterilization procedures prescribed in the device's instructions for use, which cause the teflon bearings to expand.The design has been improved and proven to prevent possible growth during clinical reprocessing.The components of this assembly was released for distribution prior to the design improvements.

Manufacturer Narrative

Reason for final (non-reportable) medwatch report: based on the present information the vigilance decision from aesculap ag was re-evaluated with the result that this incident is classified as non-serious incident and is therefore not reportable.Reason for re-evaluation was the outcome of external risk assessment "distributed product risk assessment executive summary aesculap complaint" as well as the internal risk assessment - product safety case "(b)(4)".The severity for the present error pattern was evaluated as "minor" with the description "if the device failed to assemble in the or< the surgeon would need to retrieve another instrument to complete the surgery, ultimately resulting in a delay in surgery.".The patient harm index was defined as "acceptable" with the description "patient harm is correctly mitigated.The product use does not present a safety concern." the allowable ppm rate is defined for 20 ppm.The calculated number of potential allowable injuries are defined with (b)(4)% ((b)(4) ppm) of patients affected.Investigation results: the complained product was provided, and therefore, was available for investigation.During the examination it could be confirmed that the device was difficult to assemble.The offset reamer handle did not assemble/disassemble as intended dur to oversized teflon bearings.In order for the product to be assembled/disassembled more force is required than the intended one.In 2021, a material change was made on the basis of continous product maintenance this made the affected product less susceptible to the failure mode described.The affected product was manufactured prior to the material change.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to manufacturer specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against this batch number.Conclusion and root cause: internal risk assessment - product safety case with internal ref.No (b)(4).The risk evaluation confirmed that the actual risk of the patient, the users, and third parties is still acceptable.Thus, with the data provided and the evaluations outlined above, a positive benefit- risk ratio for product nf936r - mios reamer shank harris, is still confirmed.No additional actions are indicated based on present risk assessment as well as the low incident rate from products with the old design.

• Brand Name: MIOS REAMER SHANK HARRIS
• 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: 18345954
• MDR Text Key: 330783044
• Report Number: 9610612-2023-00269
• Device Sequence Number: 1
• Product Code: MQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NF936R
• Device Catalogue Number: NF936R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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