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

Model Number NB075K

Device Problem Unsealed Device Packaging (1444)

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

Event Type  Injury  

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 enduro tibia.According to the customer description, it was reported that the sterile packaging was faulty, so that when the unsterile nurse unpacked or handed the implant, it fell out of the packaging onto the floor.No identical implant was available.The 4mm tibial wedge is only available once per side.The height of the inlay was reduced by 4mm (14mm to 10mm) (inlay was not yet open) and the wedges were increased by 4mm (4mm to 8mm), which clinically leads to the same result and has no disadvantages for the patient during the treatment.An additional medical intervention was necessary.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).

Manufacturer Narrative

The complained device and packaging was examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The outer cardboard packaging shows no serious damages.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.Additionally the implant was part of a loan service.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.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.Probably the damages of the inner and outer sterile packaging was caused due to several shipping cycles to several hospitals.We initiated a product safety case.After the 8 d report no capa is necessary.

• Brand Name: 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: 10564158
• MDR Text Key: 208543069
• Report Number: 9610612-2020-00509
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB075K
• Device Catalogue Number: NB075K
• Device Lot Number: 52152406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention