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

Model Number NB075Z

Device Problems Contamination (1120); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the packaging of an enduro tibia hemi-wedge.According to the complaint description the unstability of the implant was identified during surgery.There was no patient harm.Additional information was not provided.The malfunction is filed under aag reference (b)(4).Involved components: nb075z - as enduro tibia hemi-wedge t3 4mm rl/lm - batch 52041421.

Manufacturer Narrative

Investigation results: visual investigation: the device as well as both inner sterile packages are available in a decontaminated condition for investigation.In the state of delivery for the examination, the explant was already completely outside the two sterile packages.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 seam revealed no deviation from the desired value.There are no indications that the package 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.Conclusion and measures / preventive measures: based upon the investigation results the root cause is transport related.There is no indication for a material-, manufacturing- or design-related failure.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.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 ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10619954
• MDR Text Key: 209603155
• Report Number: 9610612-2020-00575
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: NB075Z
• Device Catalogue Number: NB075Z
• Device Lot Number: 52041421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NB075Z - BATCH 52041421.; NB075Z - BATCH 52041421.; NB075Z - BATCH 52041421