MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIAL COMP.OFFSET CEMENTED T1; KNEE ENDOPROSTHETICS

Model Number NB011K

Device Problems Delivered as Unsterile Product (1421); Expiration Date Error (2528)

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

Event Date 07/06/2021

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 nb011k - enduro tibial comp.Offset cemented t1.According to the complaint description, the subsequent implant delivery was with expired sterile date.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results.Visual investigation.The provided device show no deviation.The correct expiry date was printed on the complete product (packaging, barcode).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 our specifications valid at the time of production.Review of the complaint history revealed that three similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: in 2016 an employee inserted the wrong expiry date manually in the sap-system for the lot number 52249627.Therefore control measures have to be defined to review manually inserted expiry dates in the logistic (in-house production).However, the correct expiry date was printed on the complete product (packaging, barcode).Based upon the investigations results a capa is not necessary.

• Brand Name: ENDURO TIBIAL COMP.OFFSET CEMENTED T1
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12204090
• MDR Text Key: 262917259
• Report Number: 9610612-2021-00519
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: NB011K
• Device Catalogue Number: NB011K
• Device Lot Number: 52249627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 11/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1