MAUDE Adverse Event Report: AESCULAP AG ACTIV L PE-INLAY 8.5MM; ACTIV L IMPLANTS

Model Number	SW965
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with sw965 - activ l pe-inlay 8.5mm.According to the complaint description, after opening the activl inlay, the tech could not get it into the plate.When it was placed, it would not slide.The staff members examined the inlay more closely and noticed an extra little piece of plastic (poly) on the lip.The technician was instructed not to compromise or cut the inlay; another product was used instead.This malfunction prolonged the surgery for 5 minutes.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Investigations results: visual evaluation: visual inspection of the received implant found a scratch and a deformation, both of which could not possibly have come from the manufacturing or packaging process.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 the damage found is not related to any production or packaging processes.It appears to have been handling errors during an attempted use.The current failure rate is within the risk analysis and therefore acceptable.

• Brand Name: ACTIV L PE-INLAY 8.5MM
• Common Device Name: ACTIV L IMPLANTS
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11807603
• Report Number: 9610612-2021-00374
• Device Sequence Number: 3535112
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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 Expiration Date: 10/01/2025
• Device Model Number: SW965
• Device Catalogue Number: SW965
• Device Lot Number: 52639946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown