MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM; KNEE ENDOPROSTHETICS

Model Number NB075Z

Device Problem Packaging Problem (3007)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with as enduro tibia.According to the description text, it was reported that the inner packing is damaged.There was no patient harm reported.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00651 (400486980 nb065z).

Manufacturer Narrative

Investigation results: visual investigation: the packaging processes in the responsible production department are validated.The packages itself will be reviewed by 100 per cent visual inspection within the production process.Therefore it is unlikely that the packages have left the production department in such a damaged condition.There are no hints that the packages was not sealed in a proper way.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.The review of risk assessment revealed that the overall risk level (severity 4 (5) probability of occurrence) according to din en iso 14971 is still acceptable.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 there is capa is not necessary.

• Brand Name: AS ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10642925
• MDR Text Key: 210715050
• Report Number: 9610612-2020-00659
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB075Z
• Device Catalogue Number: NB075Z
• Device Lot Number: 52322218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1