MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV FEM.SPACER DIST.F4 5MM; KNEE ENDOPROSTHETICS

Model Number	NR464Z
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site 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 ag that an as columbus rev fem.Spacer dist.F4 5mm (part # nr464z) was to be implanted during a left knee revision procedure performed on (b)(6) 2021.According to the complainant, both the outer and inner packaging of the as columbus rev f femur cemented f4l (part # nr004z) (ref.Mdr id 9610612-2021-00656) had been cut through.Slits were identified toward the bottom of the packaging.Reportedly, a ten (10) to (15) minute procedural delay occurred and the size of the device has to be increased from four (4) to five (5).Additionally, the as columbus rev fem.Spacer dist.F4 5mm (part # nr464z) had to be swapped out as a result of having to move to the next larger device size.The complaint device has been returned to the manufacturer for evaluation.A modified surgical procedure was necessary.The adverse event is filed under (b)(4) reference (b)(4).Associated medwatch-reports 9610612-2021-00656 ((b)(4) nr004z).9610612-2021-00708 ((b)(4) nr464z).
Event or Problem Description
Correction: added patient harm "additional medical intervention necessary" an additional medical intervention was necessary.Associated medwatch-reports: 9610612-2021-00656 ((b)(4)- nr004z).9610612-2021-00708 ((b)(4)- nr464z).
Additional Manufacturer Narrative
Investigation results: visual investigation: the screw is no more fixed in the spacer as intended.The components were examined visually and microscopically with the digital microscope and the digital-camera.The screw is no more fixed in the spacer as intended.Both metal parts are now in contact and rub against each other.As a result of this smallest metal particles come loose and make the product unusable.The packaging (inner and outer sterile packaging) do not show any damage.The sealed seam of both sterile packages show also no damages.The outer sterile packaging shows 2 insertion points most likely caused by a staple.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 a psc 2021-089 was created and the pra will be adjusted accordingly if required for this failure/error.

• Brand Name: AS COLUMBUS REV FEM.SPACER DIST.F4 5MM
• Common Device Name: 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: 12780027
• Report Number: 9610612-2021-00708
• Device Sequence Number: 17648664
• Product Code: JWH
• UDI-Device Identifier: 04046963177164
• UDI-Public: 4046963177164
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: NR464Z
• Device Catalogue Number: NR464Z
• Device Lot Number: 52575368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown