MAUDE Adverse Event Report: AESCULAP AG IQ MEDIALIZED TIBIA CUTTING GUIDE LEFT; KNEE ENDOPROSTHETICS

Model Number NS406R

Device Problems Material Frayed (1262); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about one ns407r iq medialized tibia cutting guide right and two ns406r iq medialized tibia cutting guide left from the (b)(6).According to the available information, there were no negative consequences for patient.Investigation: sharp-edged burrs at the outer ends of the cutting slot.The components were examined visually and microscopically.On the production side no failure could be found.Batch history review: the device quality and manufacturing history records have been checked for the available lot numbers and found to be according to our specification valid at the time of production.Two similar incident have been filed with products from the batch 52516440 and two similar incident have been filed with products from the batch 52516441.No similar incidents have been filed with products from the other batch 52526299.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably usage related.Rationale: there are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.According to the manufacturing process and specified targets it can be excluded that the device has left aag with such sharp-edged burrs at the outer ends of the cutting slot.Most probably the device was not used as intended.Corrective action: according to (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

It was reported that there was an issue with tibia cutting guide left.It was reported that the tibia cutting guide has a metal degree on the side.This results in a risk of injury for the surgeon.There was no patient harm.An additional medical intervention was not necessary.Additional information was not provided nor available.The adverse malfunction is filed under aag (b)(4).Associated medwatch-reports: 9610612-2019-00751 ((b)(4) ns407r); 9610612-2019-00753 ((b)(4) ns406r).

• Brand Name: IQ MEDIALIZED TIBIA CUTTING GUIDE LEFT
• Type of Device: KNEE 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9317477
• MDR Text Key: 179131946
• Report Number: 9610612-2019-00752
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS406R
• Device Catalogue Number: NS406R
• Device Lot Number: 52526299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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
• Patient Outcome(s): Disability