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

Model Number NB075Z

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation results: the complained device and packaging was examined visually and microscopically.The sealed seam of the inner and outer sterile packaging was penetrated/damaged by the implant from inside out.The visual inspection of the sealed seams including a peel force test revealed no deviation from the desired value.There are no indications that the packages were not sealed in a proper way.During the investigation tiniest damages of the packages could be determined.These damages lead to a loss of the vacuum inside the packaging.As a consequence of this, the freedom of movement of the device in the packaging is widening, whereby high forces act on the sealed seams and lead finally to the breakthrough.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 can be excluded that the packages have left the aag in such a damaged condition." the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of our investigation the root cause of the failure is most probably transport related.Probably the damages of the inner and outer sterile packaging was caused due to several shipping cycles to several hospitals.

Event Description

It was reported that there was an issue with the packaging of the product as enduro tibia hemi-wedge t3 4 mm rl/lm.During an enduro surgery, the packaging of both implants was damaged and therefore no longer sterile.One time the primary packaging was affected, the other time the secondary packaging.There was no patient harm.There was an slight delay in surgery.Additional information was not provided.The adverse event/malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 400443392_9610612-2019-00651.

• Brand Name: AS ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9119989
• MDR Text Key: 160322454
• Report Number: 9610612-2019-00652
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: NB075Z
• Device Catalogue Number: NB075Z
• Device Lot Number: 52000279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2014
• 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