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

Model Number	NR584Z
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 9610612-2021-00363
• Device Sequence Number: 4181206
• Product Code: JWH
• UDI-Device Identifier: 04046963988708
• UDI-Public: 4046963988708
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown