MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV FEM.SPACER POST.F4 15MM; KNEE ENDOPROSTHESES

Model Number NR584Z

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That an as columbus rev fem.Spacer post.F4 15mm (part # nr584z) was to be implanted during a procedure performed on (b)(6) 2021.According to the complainant, black debris was observed on the implant as well as inside the sterile packaging.The complaint device was returned to the manufacturer for evaluation.This malfunction prolonged the surgery for 5-10 minutes.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the implant, as well as the corresponding packaging shows visible dark residues/discoloration.The components were examined visually and microscopically with the digital microscope.In the incoming condition the screw was no longer screwed into the implant.The surface of the implant, as well as the corresponding packaging shows visible dark residues/discoloration.An edx/ftir analysis was performed to determine the discoloration.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 no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results aa product safety case ((b)(4)) was created.

• Brand Name: AS COLUMBUS REV FEM.SPACER POST.F4 15MM
• Type of Device: KNEE ENDOPROSTHESES
• 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: 11794119
• MDR Text Key: 253239425
• Report Number: 9610612-2021-00363
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 04046963988708
• UDI-Public: 4046963988708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

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: 09/01/2022
• Device Model Number: NR584Z
• Device Catalogue Number: NR584Z
• Device Lot Number: 51883521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1