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

Model Number NB075K

Device Problems Unsealed Device Packaging (1444); Shipping Damage or Problem (1570)

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

Event Date 06/09/2021

Event Type  Injury  

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 nb075k - enduro tibia hemi-wedge t3 4mm rl/lm.According to the complaint description, both tibial wedges had been punctured by the sterile packaging and were therefore non-sterile.One of the wedges nb065k fell directly out of the sterile packaging onto the floor during handover.Nb075k had clearly leaked through the sterile packaging.An additional medical intervention was necessary.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00480 ((b)(4)- nb065k).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: 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: 12102253
• MDR Text Key: 266229372
• Report Number: 9610612-2021-00479
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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: 52107302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention