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

Model Number NB065Z

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: 9610612-2020-00659 (400486981 nb075z).

Manufacturer Narrative

Reference code (b)(4).Device name as enduro tibia hemi-wedge t3 4mm rm/ll serial number n/a.Batch number 52321351.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2017-03-13.Investigation: the complained device and packaging was examined visually and microscopically with the digital microscope and digital-camera.The sealed seam of the inner - and outer sterile packaging is damaged from inside out.The sealed seam is not yet completely pierced.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale the packaging processes in the responsible production department are validated.The vpackages 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.Probably the damages of the inner and outer sterile packaging was caused due to several shipping cycles to several hospitals.According the results of the 8d report no capa is necessary.

Event Description

Associated medwatch-reports: 9610612-2020-00659 (400486981 nb075z).

• Brand Name: AS ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10642961
• MDR Text Key: 210658304
• Report Number: 9610612-2020-00651
• 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: 12/01/2020

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: NB065Z
• Device Catalogue Number: NB065Z
• Device Lot Number: 52321351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1